Download Airways Register Search update 2008

Airways Register Search update 2008-Sept 2010
1. Agostinis F, Foglia C, Bruno ME, Falagiani P (Pediatric Division, Ospedali Riuniti, Bergamo.). Efficacy,
safety and tolerability of sublingual monomeric allergoid in tablets given without up-dosing to
pediatric patients with allergic rhinitis and/or asthma due to grass pollen. , English. European Annals
of Allergy & Clinical Immunology 2009 Dec;41(6):177-80.
Keywords: AIRWAYS ID: AST/ Administration, Sublingual/ Adolescent/ *Asthma/ th [Therapy]/
Child/ Desensitization, Immunologic/ ae [Adverse Effects]/ *Desensitization, Immunologic/ Female/
Humans/ Male/ *Plant Extracts/ ad [Administration & Dosage]/ *Poaceae/ im [Immunology]/
*Pollen/ im [Immunology]/ Prospective Studies/ *Rhinitis, Allergic, Perennial/ th [Therapy]/
*Rhinitis, Allergic, Seasonal/ th [Therapy]/ Tablets
Notes: PUBLICATION TYPE: Journal Article
PUBLICATION TYPE: Randomized Controlled Trial
Abstract: The efficacy and safety of monomeric allergoid (Lofarma, Milan) have been demonstrated
in adults but very few studies have examined it in children. This study therefore investigated the
efficacy and safety of this sublingual immunotherapy (SLIT) at the dosage of 1000 AU five times a
week without any up-dosing. Forty allergic children (17 M and 23 F, mean age 7 years, range 4-16
years), 16 with rhinitis and 24 with rhinitis and asthma, were randomized to SLIT or drug therapy.
All the patients were sensitized to grass; some were also sensitized, though to a lesser extent, to
Parietaria, Olea and Betulaceae. The patients were treated pre-/co-seasonally for two years. A visual
analogue scale (VAS) was used at baseline and at the end of the first and second pollen seasons to
rate the patients' well-being. The VAS score was significantly higher after both the first and the
second year of treatment in the SLIT group than in the controls (p<0.05). It improved in comparison
to baseline only in the active group. All 40 children tolerated the therapy very well. The monomeric
allergoid at the dosage of 5000 AU/week thus appears to have a good efficacy and safety profile in
children.
2. Aldana D, Prieto L, Palacios R, Perez-Frances C, Ferrer A, Lopez V et al. Allergen-specific Immunotherapy
with Purified nAlt a1: Effects on AMP Responsiveness, Exhaled Nitric Oxide and Exhaled Breath
Condensate pH [Abstract]. doi: DOI: 10.1016/j.jaci.2009.12.480. Journal of Allergy and Clinical
Immunology 2010;125(2 Suppl 1):AB122.
Keywords: AIRWAYS ID: AST/ asthma; allergic rhinitis
3. Antonova LP, Romanov VV, Averbakh MM. [Experience with bronchomunal used in the combined
treatment of patients with bronchial asthma and chronic obstructive pulmonary disease]. [Russian].
Problemy Tuberkuleza I Boleznej Legkih 2008; (4):8-11.
Keywords: AIRWAYS ID: AST/ COPD/ *Adjuvants, Immunologic/ tu [Therapeutic Use]/
Antibodies, Anti-Idiotypic/ an [Analysis]/ *Asthma/ dt [Drug Therapy]/ Asthma/ im [Immunology]/
Bacteria/ *Cell Extracts/ tu [Therapeutic Use]/ Female/ Follow-Up Studies/ Humans/ Immunity,
Cellular/ ph [Physiology]/ Immunoenzyme Techniques/ Immunoglobulins/ im [Immunology]/ Male/
*Pulmonary Disease, Chronic Obstructive/ dt [Drug Therapy]/ Pulmonary Disease, Chronic
Obstructive/ im [Immunology]/ T-Lymphocytes/ de [Drug Effects]/ T-Lymphocytes/ im
[Immunology]/ Treatment Outcome
Notes: PUBLICATION TYPE: Comparative Study
PUBLICATION TYPE: English Abstract
PUBLICATION TYPE: Journal Article
Abstract: The paper presents the results of treatment in 30 patients aged 16-59 years who have
bronchial asthma and chronic obstructive pulmonary disease, by using a bacterial vaccine
(bronchomunal) containing antigens of opportunistic bacteria: Streptococcus pneumoniae,
Haemophilus influenzae, Klebsiella pneumoniae, Staphylococcus aureus, Streptococcus viridans,
Streptococcus piogenes, Moraxella catarrhalis. Immunotherapy with the vaccine had good and
excellent effects in 73.33 of cases; the mean duration of acute respiratory viral infection decreased
from 16 to 9 days after vaccination and a need for antibiotics. In the comparison group, a good effect
was noted in 40% of the patients during one-year follow-up; the difference was statistically
significant. The vaccine's tolerance was good; only 3 (9.9%) patients were observed to have
vaccination-induced complications: exacerbations of chronic maxillary sinusitis and chronic
bronchitis in 2 and 1 patients, respectively. The positive effect of bronchomunal was associated with
the better values of cellular immunity, stabilized phagocytosis, and lower IgE levels.
4. Ariano R, Incorvaia C, La Grutta S, Marcucci F, Pajno G, Sensi L, Di Cara G, Sieber J, Yacoub MR, Frati F
(Allergy Department, ASL1 Imperiese, Bordighera, Italy.). Safety of sublingual immunotherapy
started during the pollen season. Current Medical Research & Opinion 2009 Jan; 25(1):103-7.
Keywords: AIRWAYS ID: AST/ Administration, Sublingual/ Adolescent/ *Allergens/ ad
[Administration & Dosage]/ *Asthma/ th [Therapy]/ Child/ Child, Preschool/ *Desensitization,
Immunologic/ ae [Adverse Effects]/ Humans/ *Pollen/ *Rhinitis, Allergic, Seasonal/ th [Therapy]
Notes: PUBLICATION TYPE: Journal Article
PUBLICATION TYPE: Research Support, Non-U.S. Gov't
Abstract: BACKGROUND: Sublingual immunotherapy (SLIT) is safer than subcutaneous
immunotherapy (SCIT) and this has lead to the reconsideration of the use of ultra-rush schedules for
SLIT. The aim of this study was to assess the safety of ultra-rush SLIT in pollen-allergic children
according to different timing of administration in relation to the pollen season. METHODS: In total,
34 children with pollen-induced rhinitis and 36 with pollen-induced asthma and rhinitis, were
enrolled and assigned to three study groups: group 1 (n = 17 patients): conventional
pre-seasonal-SLIT treatment; group 2 (n = 23 patients), seasonal SLIT ended before the pollen
seasonal peak; group 3 (n = 30 patients), SLIT began after the pollen seasonal peak and ended after
the pollen season. SLIT was performed using extracts from Stallergenes (Antony, France) and
following an ultra-rush schedule, consisting in four doses at a 30-min intervals, and maintenance
treatment by administering the top dose three times a week. RESULTS: In all, 54 adverse events
(AEs) were reported: 12 in nine patients in group 1 (9/17, 52.9%), 22 in 14 patients in group 2
(14/23, 60.9%), and 20 in 13 patients in group 3 (13/30, 43.3%). No statistically significant
differences were found between the three groups. Local AEs (oral itching and burning) were short
lasting and self-resolving. Systemic AEs were also mild, except for a case of asthma, which lasted 5
days, in a patient from group 1. There were no severe reactions, and none of the patients dropped
out. CONCLUSIONS: This study suggests that SLIT with pollen extracts may be safely started at
the beginning and also during the pollen season, with a tolerability profile comparable to the
conventional pre-seasonal SLIT.
5. Armentia-Medina A, Tapias JA, Martín JF, Ventas P, Fernández A. Immunotherapy with the storage mite
lepidoglyphus destructor [Immunotherapy with the storage mite lepidoglyphus destructor].
CN-00662688. Allergologia Et Immunopathologia 1995;23(5):211-23.
Keywords: AIRWAYS ID: AST
6. Blaziene A, Leisyte P, Sitkauskiene B, Kits L, Savisaar M, Lozovskis V, Bukovskis M, Maurer P, Willers J,
and Mueller P. Cyt003-Qbg10, a novel allergen-independent immunotherapy, shown to be safe and
efficacious for treating allergic rhino-conjunctivitis and asthma in placebo-controlled phase II study.
CN-00725130. Allergy 2009;64(s90):74 [159].
Keywords: AIRWAYS ID: AST
7. Bochenska-Marciniak M, Tworek D, Kupczyk M, Bogacka E, Kuprys-Lipinska I, Kuna P. The effectiveness
of allergen immunotherapy depending on the regimen on rhinoconjunctivitis and asthma symptoms
in allergy to grass pollen [Abstract]. American Thoracic Society International Conference, May
15-20, 2009, San Diego 2009; A2781 [Poster #J50].
Keywords: AIRWAYS ID: AST/ asthma
8. Bufe A, Eberle P, Franke-Beckmann E, Funck J, Kimmig M, Klimek L, Knecht R, Stephan V, Tholstrup B,
Weisshaar C, et al. Safety and efficacy in children of an SQ-standardized grass allergen tablet for
sublingual immunotherapy. CN-00666110. The Journal of Allergy and Clinical Immunology
2009;123(1):167-73.e7.
Keywords: AIRWAYS ID: AST/ Adolescent; Antigens, Plant [administration & dosage] [adverse
effects]; Asthma [immunology] [therapy]; Conjunctivitis, Allergic [immunology] [therapy];
Double-Blind Method; Immunotherapy; Poaceae [adverse effects] [immunology]; Pollen [adverse
effects] [immunology]; Rhinitis, Allergic, Seasonal [immunology] [therapy]; Time Factors; Child;
Child, Preschool; Female; Humans; Male
Notes: Publication Type: Journal Article; Multicenter Study; Randomized Controlled Trial
Abstract: BACKGROUND: Immunotherapy with the SQ-standardized grass tablet Grazax is
efficacious and well-tolerated in adult patients with rhinoconjunctivitis. Allergic asthma and
rhinoconjunctivitis are closely linked, and a strategy combining treatment of the upper and lower
airways is recommended. OBJECTIVE: To investigate the efficacy of treatment with the grass tablet
on grass pollen-induced rhinoconjunctivitis and asthma as well as the immunologic response and the
safety profile in children. METHODS: A total of 253 children age 5 to 16 years, with grass
pollen-induced rhinoconjunctivitis with/without asthma, were randomized 1:1 to active treatment or
placebo. Treatment was initiated 8 to 23 weeks before the start of the grass pollen season 2007 and
continued throughout the entire season. Symptomatic medication was provided as relief medication
to both groups in a stepwise fashion. Primary endpoints were rhinoconjunctivitis symptom and
medication scores. RESULTS: The rhinoconjunctivitis symptom and medication scores and the
asthma symptom score were all statistically significantly different between the 2 treatment groups.
The differences in medians relative to placebo were 24%, 34%, and 64% in favor of active
treatment. The immunologic response was similar to that observed in adults. The most common
adverse reaction was oral pruritus, reported by 40 subjects (32%) in the active and 3 (2%) in the
placebo group. Six subjects withdrew because of adverse events. No serious adverse events were
assessed as treatment-related. CONCLUSION: Immunotherapy with the grass tablet reduced grass
pollen-induced rhinoconjunctivitis and asthma symptoms in a pediatric population and introduced an
immunomodulatory response, consistent with treatment of the underlying allergic disease. The
treatment was well tolerated.
9. Bush R, Swenson C, Fahlberg B, Bernstein J, Gaworski K, Sanchez H, Esch R, and Busse W. Safety of
sublingual house dust mite (HDM) immunotherapy: a randomized, double-blind, placebo-controlled
U.S. trial. CN-00691452. Journal of Allergy & Clinical Immunology 2009;123(2 Suppl 1):Abstract
No. 273.
Keywords: AIRWAYS ID: AST
Abstract: American Academy of Allergy, Asthma and Immunology (AAAAI) 65th Annual Meeting,
March 13-17, 2009, Washington, USA
10. Bush R, Swenson C, Fahlberg B, Bernstein J, Gaworski K, Sanchez H, Esch R, Busse W. Safety of
Sublingual House Dust Mite (HDM) Immunotherapy: A Randomized, Double-blind,
Placebo-controlled U.S. Trial [Abstract]. doi: DOI: 10.1016/j.jaci.2008.12.255. Journal of Allergy
and Clinical Immunology 2009;123(2 Suppl 1):S74.
Keywords: AIRWAYS ID: AST/ allergic rhinitis; asthma;
Abstract: American Academy of Allergy Asthma & Immunology (AAAAI) Annual Meeting 2009
11. Cadario G, Ciprandi G, Di Cara G, Fadel R, Incorvaia C, Marcucci F, Marengo F, Puccinelli P, Sensi L,
Strazzeri L, et al. Comparison between continuous or intermittent schedules of sublingual
immunotherapy for house dust mites: effects on compliance, patients satisfaction, quality of life and
safety. CN-00643393. International Journal of Immunopathology & Pharmacology
2008;21(2):471-3.
Keywords: AIRWAYS ID: AST
Abstract: Sublingual immunotherapy (SLIT) is indicated in the treatment of allergic rhinitis and
asthma. However, an issue scantly investigated is the patients satisfaction and the consequent
compliance. This study is aimed at evaluating the possible differences of SLIT administered
continuously or intermittently on several parameters: clinical efficacy, Quality of Life (QoL),
satisfaction, compliance and safety. Forty allergic patients were treated for 12 months. The treatment
was carried out by sublingual administration of an allergen extract of a 50% mixture of
Dermatophagoides pteronyssinus and Dermatophagoides farinae at 10 and 300 IR/ml concentrations.
Patients were randomly treated continuously or intermittently (i.e. 2 month treatment alternate to 2
month suspension). Both schedules were significantly effective in reducing allergic symptoms and
improving QoL. Compliance and satisfaction were good in both groups. Local and systemic
reactions were few, self-resolving, and mild in both schedules. Intergroup analysis did not reveal any
difference between the two groups regarding these parameters. In conclusion, this preliminary study
provides the evidence that also intermittent SLIT is as effective and safe as traditional continuous
treatment. In addition, compliance and satisfaction are super-imposable in the two groups.
12. Cao LF, Lu Q, Gu HL, Chen YP, Zhang Y, Lu M, Qian YQ, Li L, and Xu YP. Clinical evaluation for
sublingual immunotherapy of allergic asthma and atopic rhinitis with dermatophagoides farinae
drops. CN-00643395. Zhonghua Er Ke Za Zhi 2007;45(10):736-41.
Keywords: AIRWAYS ID: AST
Abstract: OBJECTIVE: To evaluate the safety and efficacy of sublingual immunotherapy with
'Dermatophagoides Farinae Drops' in D. farinae allergic asthma and/or rhinitis patients. METHODS:
A 25-week double-blind, placebo-controlled, multi-centered trail was conducted in 278 children
(aged 4 - 18 yr) with mite-induced asthma and/or rhinitis. Patients were randomly assigned to
receive sublingual immunotherapy (SLIT) with 'Dermatophagoides Farinae Drops' (n = 139) or
placebo (n = 139) for 25 weeks and the dosage and administration strictly followed the
manufacturer's instructions. At the beginning of the 2nd, 3rd, 4th, 6th, 10th, 14th, 18th, 22nd week
of the treatment, the patients were asked to accept follow-up visit, during the clinical trial all patients
and parents were asked to keep a daily record of their asthma symptom scores, rescue medicine use,
rhinitis symptom scores, morning and evening peak expiratory flow. Asthma symptom scores,
reduction in use of rescue medicine, rhinitis symptom scores, lung function tests, skin sensitivity to
mite, mite-specific immunoglobulin (Ig) E and IgG4, and quality of life and adverse effect were
assessed during the study. RESULT: (1) Of the 278 children, 27 dropped out before the study
completion. (2) After 25 weeks of treatment, the median variability of PEFR was -1.38 for SLIT
group and -0.90 for the placebo (P < 0.05). (3) Besides, the mean variability of medicine score of
asthma was -0.08 for SLIT group and 0.52 for the plcebo (P < 0.05). (4) The median variability of
rhinitis symptom score was -1.96 for SLIT group and -1.03 for the placebo (P < 0.01). (5) The rescue
medicine usage of SLIT reduced but did not show significant differences between SLIT and placebo.
(6) After 25 weeks treatment, the increase of D. farinae specific IgE antibody of two groups were
similar, while specific IgG4 increased significantly in SLIT compared to the patients in control one
(P < 0.01); (7) No severe adverse events happened in the trial and the most-likely adverse events
were mild asthma and local rash. CONCLUSION: Dermatophagoides Farinae Drops is safe and
effective in treating allergic asthma and atopic rhinitis.
13. Chen Z G , Chen Y F , Li M , Ji J Z , Chen F H , Chen H (Department of Pediatrics, Third Affiliated
Hospital of Sun Yat-sen University, Guangzhou, China. [email protected]). [Effects of
Dermatophagoides pteronyssinus allergen-specific immunotherapy on the prognosis of asthmatic
children]. [Chinese], Chinese. Nan Fang Yi Ke Da Xue Xue Bao = Journal of Southern Medical
University 2009 Jun; 29(6):1179-81.
Keywords: AIRWAYS ID: AST/ Adolescent/ *Allergens/ im [Immunology]/ *Antigens,
Dermatophagoides/ im [Immunology] / Asthma/ im [Immunology]/ *Asthma/ th [Therapy]/ Child/
Child, Preschool/ *Desensitization, Immunologic/ mt [Methods]/ Female/ Humans/
Interferon-gamma/ bl [Blood]/ Interleukin-4/ bl [Blood]/ Male/ Prognosis/ Respiratory Function
Tests/ Th1 Cells/ im [Immunology]/ Th2 Cells/ im [Immunology]
Notes: PUBLICATION TYPE: Controlled Clinical Trial
PUBLICATION TYPE: English Abstract
PUBLICATION TYPE: Journal Article
PUBLICATION TYPE: Research Support, Non-U.S. Gov't
Abstract: OBJECTIVE: To investigate the effects of Dermatophagoides pteronyssinus
allergen-specific immunotherapy (SIT) on the prognosis of asthmatic children. METHODS:
Sixty-five children with established diagnosis of allergic asthma to dust mite were enrolled in this
study, of whom 42 children received treatment with standardized SIT for 12 month and the other 23
served as the control group with inhaled corticosteroids according to Global Initiative for Asthma
(GINA). The serum levels of interleukin-4 (IL-4) and interferon-gamma (IFN-gamma) were detected
and the pulmonary functions examined before and after the one-year treatment in all the patients.
RESULTS: After the one-year treatment with SIT, the asthmatic children showed obviously reduced
serum levels of IL-4, significantly increased IFN-gamma levels and the IFN-gamma/IL-4 ratio
(P<0.05), and markedly improved pulmonary functions (FVC, pre-FEV1% and pre-PEF%) (P<0.05).
In the control group, the children exhibited significantly increased IFN-gamma levels and
IFN-gamma/ IL-4 ratio (P<0.05) without obvious reduction of serum IL-4 levels or pulmonary
function improvement (P>0.05). With comparable basic pulmonary functions in the two groups
before the treatment, the children in SIT group showed significantly greater improvement in the
pulmonary functions than those in the control group after the one-year treatment. CONCLUSION:
The one-year treatment with SIT can significantly improve the pulmonary functions of children with
allergic asthma, and this effect is attributed to the regulation of Th1/Th2 cell balance and inhibition
of asthmatic airway remodeling by SIT.
14. Chen ZG, Li M, Chen YF, Ji JZ, Li YT, Chen W, Chen FH, Chen H (Department of Pediatrics, Third
Hospital Affiliated to Sun Yat-sen University, Guangzhou, Guangdong, China.). Effects of
dermatophagoides pteronyssinus allergen-specific immunotherapy on the serum interleukin-13 and
pulmonary functions in asthmatic children., English. Chinese Medical Journal 2009 May 20;
122(10):1157-61.
Keywords: AIRWAYS ID: AST/ Adolescent/ Animals/ *Antigens, Dermatophagoides/ im
[Immunology]/ Asthma/ bl [Blood]/ Asthma/ im [Immunology]/ *Asthma/ th [Therapy]/ Child/
Child, Preschool/ *Dermatophagoides pteronyssinus/ im [Immunology]/ Enzyme-Linked
Immunosorbent Assay/ Female/ Humans/ *Immunotherapy/ mt [Methods]/ Interferon-gamma/ bl
[Blood]/ Interleukin-13/ bl [Blood]/ Interleukin-4/ bl [Blood]/ Male
Notes: PUBLICATION TYPE: Clinical Trial
PUBLICATION TYPE: Journal Article
PUBLICATION TYPE: Research Support, Non-U.S. Gov't
Abstract: BACKGROUND: Airway remodeling is the specific pathological characteristics of
asthma, which is related to the clinical symptoms, pulmonary function, and airway hyperreactivity.
This study aimed at exploring the effects of dermatophagoides pteronyssinus allergen-specific
immunotherapy (SIT) on the serum interleukin (IL)-13 and pulmonary functions in asthmatic
children. METHODS: Fifty-eight pediatric asthma patients allergic to dust mite participated in this
study. Thirty-five children received SIT with a standardized dermatophagoides pteronyssinus extract
for one year (SIT group), and the other 23 children treated with inhaled corticosteroids (ICS group)
according to the Global Initiative for Asthma (GINA) for one year. Serum levels of IL-13, IL-4 and
interferon (IFN)-gamma were examined and the pulmonary functions were checked before and after
the treatment. RESULTS: After the treatment, the number of emergency visiting for asthma attack in
SIT group was significantly less than that in ICS group. The serum levels of IL-4 and IL-13 were
clearly reduced, IFN-gamma and the ratio of IFN-gamma/IL-4 were significantly increased, the
pulmonary functions (forced vital capacity (FVC), forced expiratory volume in one second
percentage (FEV(1)%) and peak expiratory flow percentage (PEF%) were significantly improved in
the SIT group. Meanwhile, IFN-gamma and the ratio of IFN-gamma/IL-4 were greatly increased, but
serum levels of IL-4 and IL-13 had less changes, the pulmonary functions (FVC, FEV(1)% and
PEF%) were poorly improved in ICS group. The basic pulmonary functions in both groups were at
the same level, which had made more improvement in SIT group than in ICS group one year later.
CONCLUSIONS: One year of dermatophagoides pteronyssinus SIT can significantly reduce the
frequencies of emergency visiting for asthma attack and improve the pulmonary functions of
children with allergic asthma, and that is attributed to SIT, which can reduce the levels of IL-4 and
IL-13 and regulate the imbalance of the Th1/Th2 cells in asthmatic children. All of these might be
effective in preventing the asthmatic airway from remodeling.
15. Cohon A. Assessment of BCG as an adjuvant in specific immunotherapy in asthmatic patients [Dissertation]
[Avaliação do BCG como adjuvante na imunoterapia específica para asmáticos]. LILACS 397931.
Universidade De São Paulo. Departamento De Clínica Médica 2004;100p.
Keywords: AIRWAYS ID: AST/ asthma; BCG vaccine;
Abstract: Decreased exposure to infectious agents has been pointed as one of the factors involved in
the increasing of allergic diseases. Immune dysfunction underlines atopy. Cytokines profile during
antigen presentation is decisive to define immune response. Association of BCG vaccine with
specific immunotherapy for Dermatophagoides pteronyssinus were assessed in double blind
randomized study in 21 asthmatic patients. Improvement in clinical symptoms and in pulmonary
function, reduction in cutaneous reactivity and in lymphoproliferation with Dpt extract and increase
in specific IgG and IL-10 levels, were observed in both groups, with or without BCG. No difference
were observed between groups.
16. D'Anneo RW, Arena A, Gammeri E, Bruno ME , Falagiani P, Riva G, Leonardi S, La Rosa M. Parietaria
sublingual allergoid immunotherapy with a co-seasonal treatment schedule. 2008298427.
Allergologia Et Immunopathologia 2008;36(2):79-84.
Keywords: AIRWAYS ID: AST/ Adult; Article; Aspergillus; *Asthma/ Dt [Drug Therapy];
Controlled Study; Dermatophagoides; Drug Safety; Female; Human; Immunotherapy; Major
Clinical Study; Male; Parietaria; *Rhinitis/ Dt [Drug Therapy]; Skin Test; Visual Analog Scale;
*Allergoid/ Cm [Drug Comparison]; *Allergoid/ Dt [Drug Therapy]; *Allergoid / Li [Sublingual
Drug Administration]; Antihistaminic Agent/ Cm [Drug Comparison]; Antihistaminic Agent/ Dt
[Drug Therapy]; Bronchodilating Agent/ Cm [Drug Comparison]; Bronchodilating Agent/ Dt [Drug
Therapy]; *Immunomodulating Agent/ Cm [Drug Comparison]; *Immunomodulating Agent/ Dt
[Drug Therapy]; *Immunomodulating Agent/ Li [Sublingual Drug Administration]; Methacholine
Abstract: Background: Sublingual immunotherapy (SLIT) with monomeric allergoid, given
according to the standard scheme, resulted effective and safe. However, the achievement of a clinical
benefit requires a long time. We thus performed this study using an administration protocol starting
in the co-seasonal period with a 3-day build-up phase and lasting only 6 months, in order to obtain
the above benefit in a shorter time. Methods and results: The study, prospective, randomised and
controlled versus drug therapy, was conducted on 65 rhinitic and/or asthmatic patients allergic to
Parietaria with or without other sensitisations. Twenty-four were allocated to 1,000 AU/week, 21 to
3,000 AU/week and 21 to drug therapy. They were treated from April to September 2006. At
baseline, 3 and 6 months a Visual Analogue Scale (VAS) was performed to assess the patients'
well-being. Drug consumption was evaluated by means of monthly diary cards. Bronchial reactivity
was investigated at baseline and 6 months by methacholine challenge test. There was a greater VAS
improvement in both the SLIT groups than in the controls after 6 months (p < 0.05). In patients
taking 3,000 AU/week this was already evident after 3 months. There was a significant reduction in
rescue medication consumption between 3 and 6 months (p < 0.05) in all three groups. The bronchial
reactivity was reduced only in the SLIT groups (p < 0.001). No adverse events were observed.
Conclusions: At 6 months the allergoid SLIT showed itself to be effective and safe. In addition the
subjective clinical benefit was obtained in a more rapid period, i.e. 3 instead of 6 months, when a
higher maintenance dose was administered.
17. de Bot CM, Moed H, Berger MY, Roder E, de Groot H, de Jongste JC, Gerth van Wijk R, and van der
Wouden JC. Randomized double-blind placebo-controlled trial of sublingual immunotherapy in
children with house dust mite allergy in primary care: study design and recruitment. CN-00652569.
BMC Family Practice 2008;9(1):59.
Keywords: AIRWAYS ID: AST
Abstract: ABSTRACT: BACKGROUND: For respiratory allergic disorders in children, sublingual
immunotherapy has been developed as an alternative to subcutaneous immunotherapy. Sublingual
immunotherapy is more convenient, has a good safety profile and might be an attractive option for
use in primary care. A randomized double-blind placebo-controlled study was designed to establish
the efficacy of sublingual immunotherapy with house dust mite allergen compared to placebo
treatment in 6 to18-year-old children with allergic rhinitis and a proven house dust mite allergy in
primary care. Described here are the methodology, recruitment phases, and main characteristics of
the recruited children. METHODS: Recruitment took place in September to December of 2005 and
2006. General practitioners (in south-west Netherlands) selected children who had ever been
diagnosed with allergic rhinitis. Children and parents could respond to a postal invitation. Children
who responded positively were screened by telephone using a nasal symptom score. After this
screening, an inclusion visit took place during which a blood sample was taken for the RAST test.
RESULTS: A total of 226 general practitioners invited almost 6000 children: of these, 51% was
male and 40% <12 years of age. The target sample size was 256 children; 251 patients were finally
included. The most frequent reasons given for not participating were: absence or mildness of
symptoms, absence of house dust mite allergy, and being allergic to grass pollen or tree pollen only.
Asthma symptoms were reported by 37% of the children. Of the enrolled children, 71% was
sensitized to both house dust mite and grass pollen. Roughly similar proportions of children were
diagnosed as being sensitized to one, two, three or four common inhalant allergens. CONCLUSION:
Our study was designed in accordance with recent recommendations for research on establishing the
efficacy of sublingual immunotherapy; 98% of the target sample size was achieved. This study is
expected to provide useful information on sublingual immunotherapy with house dust mite allergen
in primary care. The results on efficacy and safety are expected to be available by 2010. Trial
registration: the trial is registered as ISRCTN91141483 (Dutch Trial Register).
18. Di Gioacchino M, Perrone A, Petrarca C, Di Claudio F, Mistrello G, Falagiani P, Dadorante V, Verna N,
Braga M, Ballone E, et al. (Allergy Related Disease Unit, G. d'Annunzio University Foundation,
Chieti, Italy. [email protected]). Early cytokine modulation after the rapid induction phase of
sublingual immunotherapy with mite monomeric allergoids. International Journal of
Immunopathology & Pharmacology 2008 Oct-2008 Dec 31; 21(4):969-76.
Keywords: AIRWAYS ID: AST/ Administration, Sublingual/ *Allergens/ ad [Administration &
Dosage]/ Animals/ *Cytokines / me [Metabolism]/ *Desensitization, Immunologic/ Humans/
*Mites/ im [Immunology]
Notes: PUBLICATION TYPE: Journal Article
Abstract: The influence of different treatment schedules of sublingual immunotherapy (SLIT) in
activating IL-10-producing T-cells, crucial in inducing allergen-specific tolerance, is not completely
understood. The present work was designed to evaluate allergen driven interleukin release by
mononuclear cells in the early phase of SLIT, after application of different induction schemes.
Twenty mite-allergic patients were enrolled, 10 (group A) treated with a traditional 98 day induction
scheme and 10 (group B) with a 16 day scheme with monomeric allergoid vaccine. At the end of the
induction phase, the cumulative doses taken by group A and group B patients were equivalent to
50.5 and 50.3 microg of mite group 1 allergens, respectively. The release of Th1-, Th2- and
Treg-related interleukins was assessed in culture supernatants of 5 microg/ml Der-p1-stimulated
mononuclear cells, isolated before and after the induction phases. No relevant treatment-related side
effects were observed. Interleukin release was similar in the two groups at the enrolment.
Non-stimulated and Der p 1 stimulated release of studied cytokines was similar in the two groups at
enrolment. Der p 1 stimulation significantly increased IL-10 release (p<0.0002) after treatment in
group B patients, and this effect was higher (p=0.05) compared to group A patients. Furthermore, at
the end of SLIT induction TNF-alpha, IL-4 and IFN-gamma production were reduced in group B
patients (p<0.05, p=0.062 and p=0.060, respectively). The rapid induction scheme of sublingual
immunotherapy induces an early immune suppression more effectively than the slower one. The
rapid induction scheme should be the preferential way to start sublingual immunotherapy,
particularly when monomeric allergoids are utilized.
19. Eifan A, Akkoc T, Yildiz A, Keles S, Tevetoglu A, Izgi A, Ozdemir C, Bahceciler N, and Barlan I. Clinical
efficacy and immunological mechanisms of sublingual and subcutaneous specific immunotherapy in
asthmatic/rhinitis children sensitised to house-dust-mite: an open randomised controlled study.
CN-00725048. Allergy 2009;64(Suppl 90):354 [P913].
Keywords: AIRWAYS ID: AST
20. Eifan AO, Akkoc T, Yildiz A, Keles S, Ozdemir C, Bahceciler NN, and Barlan IB. Clinical efficacy and
immunological mechanisms of sublingual and subcutaneous immunotherapy in asthmatic/rhinitis
children sensitized to house dust mite: an open randomized controlled trial. CN-00738724. Clinical
& Experimental Allergy 2010;40(6):922–932.
Keywords: AIRWAYS ID: AST
21. Fancello P, Atzeni I, and Bruno M. Sublingual allergoid immunotherapy with a 4-day updosing phase versus
traditional initial scheme, or drugs alone. A controlled, randomised study in rhinitic patients with or
without mild allergic asthma. CN-00691592. Allergy 2008;63(s88):Abstract No. 1067.
Keywords: AIRWAYS ID: AST
Abstract: XXVII EAACI Congress of the European Academy of Allergology and Clinical
Immunology, June 7-11, 2008, Barcelona, Spain
22. Feary J, Venn A, Brown A, Hooi D, Falcone FH, Mortimer K, Pritchard DI, Britton J (J. Feary, Division of
Epidemiology and Public Health, University of Nottingham, City Hospital, Nottingham NG5 1PB,
United Kingdom. E-mail: [email protected]). Safety of hookworm infection in
individuals with measurable airway responsiveness: A randomized placebo-controlled feasibility
study. 2009280499, English. Clinical and Experimental Allergy 2009;39(7):1060-8.
Keywords: AIRWAYS ID: AST/ Adult; Article; *Asthma; *Bronchus Hyperreactivity/ Th
[Therapy]; Clinical Article; Clinical Trial; Controlled Clinical Trial; Controlled Study; Cutaneous
Larva Migrans; Double Blind Procedure; Eosinophil Count; Female; Human; Immunotherapy; Male;
Necator Americanus; Priority Journal; Randomized Controlled Trial; *Rhinoconjunctivitis; Risk
Assessment; Adenosine Phosphate; Histamine
Notes: Publication Type: Journal: Article
Abstract: Background Epidemiological evidence suggests that hookworm infection protects against
asthma. However, for ethical and safety reasons, before testing this hypothesis in a clinical trial in
asthma it is necessary to establish whether experimental hookworm infection might exacerbate
airway responsiveness during larval lung migration. Objective To determine whether hookworm
larval migration through the lungs increases airway responsiveness in allergic individuals with
measurable airway responsiveness but not clinical asthma, and investigate the general tolerability of
infection and effect on allergic symptoms. Methods Thirty individuals with allergic
rhinoconjunctivitis and measurable airway responsiveness to adenosine monophosphate (AMP) but
not clinically diagnosed asthma were randomized, double-blind to cutaneous administration of either
10 hookworm larvae or histamine placebo, and followed for 12 weeks. The primary outcome was the
maximum fall from baseline in provocative dose of inhaled AMP required to reduce 1-s forced
expiratory volume by 10% (PD10AMP) measured at any time over the 4 weeks after active or
placebo infection. Secondary outcomes included peak flow variability in the 4 weeks after infection,
rhinoconjunctivitis symptom severity and adverse effect diary scores over the 12-week study period,
and change in allergen skin test responses between baseline and 12 weeks. Results Mean maximum
change in PD 10AMP from baseline was slightly but not significantly greater in the hookworm than
the placebo group (-1.67 and -1.16 doubling doses; mean difference -0.51, 95% confidence interval
-1.80 to 0.78, P=0.42). Symptom scores of potential adverse effects were more commonly reported
in the hookworm group, but infection was generally well tolerated. There were no significant
differences in peak-flow variability, rhinoconjunctivitis symptoms or skin test responses between
groups. Conclusion Hookworm infection did not cause clinically significant exacerbation of airway
responsiveness and was well tolerated. Suitably powered trials are now indicated to determine the
clinical effectiveness of hookworm infection in allergic rhinoconjunctivitis and asthma. copyright
2009 Blackwell Publishing Ltd
23. Imperial College London. Randomized double blind placebo controlled trial of grass pollen immunotherapy
using a cluster regime [completed]. CN-00652657. ClinicalTrials.Gov [Accessed 31 Jul 2008] 2008.
Keywords: AIRWAYS ID: AST
Abstract: The purpose of this study was to assess the effects of grass pollen immunotherapy on
symptoms, bronchial hyperresponsiveness and quality of life in seasonal rhinitis and asthma. Hay
fever symptoms and medication use, health-related quality of life, and measurements of non-specific
bronchial responsiveness were recorded during the study period. ClinicalTrials.gov ID:
NCT00135642
24. Inal A, Kendirli S, Yilmaz M, Altintas D, and Karakoc G. Effect of subcutaneous and sublingual
immunotherapy on clinical improvement and quality of life in children with rhinitis and asthma
monosensitised to house dust mite: a randomised, placebo-controlled, double-blind, double-dummy
study. CN-00725051. Allergy 2009;64(Suppl 90): 462 [P1209].
Keywords: AIRWAYS ID: AST
25. Jacobsen L, Niggemann B, Dreborg S, Ferdousi HA, Halken S, Hųst A, Koivikko A, Norberg LA, Valovirta
E, Wahn U, et al. Specific immunotherapy has long-term preventive effect of seasonal and perennial
asthma: 10-year follow-up on the PAT study. CN-00700669. Allergy 2007;62(8):943-8.
Keywords: AIRWAYS ID: AST/ Adolescent; Allergens [immunology] [therapeutic use]; Asthma
[complications] [immunology] [prevention & control]; Betula [immunology]; Bronchial Provocation
Tests [methods]; Desensitization, Immunologic [methods]; Follow-Up Studies; Longitudinal
Studies; Odds Ratio; Pain Measurement [methods]; Plant Proteins [immunology] [therapeutic use];
Poaceae [immunology]; Pollen; Rhinitis, Allergic, Seasonal [complications] [immunology]
[prevention & control]; Risk Factors; Skin Tests [methods]; Time; Adult; Female; Humans; Male
Notes: Publication Type: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S.
Gov't
Abstract: BACKGROUND: 3-year subcutaneous specific immunotherapy (SIT) in children with
seasonal allergic rhinoconjunctivitis reduced the risk of developing asthma during treatment and 2
years after discontinuation of SIT (5-year follow-up) indicating long-term preventive effect of SIT.
OBJECTIVE: We evaluated the long-term clinical effect and the preventive effect of developing
asthma 7-years after termination of SIT. METHODS: One hundred and forty-seven subjects, aged
16-25 years with grass and/or birch pollen allergy was investigated 10 years after initiation of a
3-year course of SIT with standardized allergen extracts of grass and/or birch or no SIT respectively.
Conjunctival provocations were performed outside the season and methacholine bronchial
provocations were performed during the season and winter. Asthma was assessed by clinical
evaluation. RESULTS: The significant improvements in rhinoconjunctivitis and conjunctival
sensitivity persisted at the 10-year follow-up. Significantly less actively treated subjects had
developed asthma at 10-year follow-up as evaluated by clinical symptoms [odds ratio 2.5 (1.1-5.9)].
Patients who developed asthma among controls were 24/53 and in the SIT group 16/64. The
longitudinal treatment effect when adjusted for bronchial hyper-responsiveness and asthma status at
baseline including all observations at 3, 5 and 10 years follow-up (children with or without asthma at
baseline, n = 189; 511 observations) was statistically significant (P = 0.0075). The odds ratio for
no-asthma was 4.6 95% CI (1.5-13.7) in favor of SIT. CONCLUSION: A 3-year course of SIT with
standardized allergen extracts has shown long-term clinical effects and the potential of preventing
development of asthma in children with allergic rhinoconjunctivitis up to 7 years after treatment.
CLINICAL IMPLICATION: Specific immunotherapy has long-term clinical effects and the
potential of preventing development of asthma in children with allergic rhino conjunctivitis up to 7
years after treatment termination.
26. Kopp MV, Hamelmann E, Zielen S, Kamin W, Bergmann KC, Sieder C, Stenglein S, Seyfried S, Wahn U
(Zentrum fur Kinder- und Jugendmedizin, University of Freiburg, Freiburg, Germany.
[email protected]). Combination of omalizumab and specific immunotherapy is
superior to immunotherapy in patients with seasonal allergic rhinoconjunctivitis and co-morbid
seasonal allergic asthma, eng. Clinical and Experimental Allergy : Journal of the British Society for
Allergy and Clinical Immunology 2009;39(2):271-9.
Keywords: AIRWAYS ID: AST/ Adolescent/ Adult/ Anti-Allergic Agents: therapeutic use/
Antibodies, Monoclonal: administration & dosage: *therapeutic use/ Antigens, Plant: therapeutic
use/ Asthma: physiopathology: *therapy/ Child/ Combined Modality Therapy: adverse effects/
Conjunctivitis, Allergic: *therapy/ Desensitization, Immunologic: adverse effects: *methods/
Double-Blind Method/ Female/ Forced Expiratory Volume: physiology/ Humans/ Male/ Middle
Aged/ Plant Extracts: therapeutic use/ Pollen: chemistry/ Quality of Life/ Respiratory Function
Tests/ Rhinitis, Allergic, Seasonal: *therapy/ Treatment Outcome/ Young Adult
Notes: Publication Type: Journal Article
Publication Type: Multicenter Study
Publication Type: Randomized Controlled Trial
Publication Type: Research Support, Non-U.S. Gov't
Abstract: BACKGROUND: The treatment of allergic asthma by specific immunotherapy (SIT) is
hampered by potential side-effects. OBJECTIVE: The aim of this study was to study the effect of
omalizumab, a monoclonal anti-IgE antibody, in combination with SIT in patients with seasonal
allergic rhinoconjunctivitis (SAR) and co-morbid seasonal allergic asthma (SAA) incompletely
controlled by conventional pharmacotherapy. METHODS: A randomized, double-blind,
placebo-controlled, multi-centre trial was performed to assess the efficacy and safety of omalizumab
(Xolair) vs. placebo in combination with depigmented SIT (Depigoid) during the grass pollen
season. Omalizumab or placebo was started 2 weeks before SIT; the whole treatment lasted 18
weeks. Primary endpoint was daily 'symptom load', the sum of daily scores for symptom severity
and rescue medication use. RESULTS: A total of 140 patients (age 11-46 years) were randomized;
and a total of 130 finished the study. Combination therapy reduced the symptom load by 39%
(P=0.0464, Wilcoxon test) over SIT monotherapy. This difference was mainly due to reduced
symptom severity (P=0.0044), while rescue medication use did not change significantly.
Combination therapy also improved asthma control (Asthma Control Questionnaire, P=0.0295) and
quality of life in the case of asthma (Asthma Quality of Life Questionnaire, P=0.0293) and
rhinoconjunctivitis (Rhinoconjunctivitis Quality of Life Questionnaire, P=0.0537). Numbers of
patients with 'excellent or good' treatment efficacy according to ratings of investigators (75.0% vs.
36.9%) or patients (78.5% vs. 46.1%) were markedly higher in the combination group than under
SIT alone. CONCLUSION: Combination of omalizumab with SIT for treatment of patients with
SAR and co-morbid SAA was safe and reduced the symptom load in a statistically significant and
clinically meaningful manner.
27. Lee RU, White AA, Ding D, Dursun AB, Woessner KM, Simon RA, Stevenson DD (A. A. White, Division
of Allergy, Asthma and Immunology, Scripps Clinic, Scripps Clinic Carmel Valley, 3811 Valley
Centre Drive, S99, San Diego, CA 92130, United States. E-mail: [email protected]).
Use of intranasal ketorolac and modified oral aspirin challenge for desensitization of
aspirin-exacerbated respiratory disease. 2010419177, English. Annals of Allergy, Asthma and
Immunology 2010; 105(2):130-5.
Keywords: AIRWAYS ID: AST/ Adult; Aged; Article; *Aspirin Exacerbated Respiratory Disease/
Dt [Drug Therapy]; Asthma/ Dt [Drug Therapy]; Clinical Examination; Clinical Protocol; Controlled
Study; *Desensitization; Diagnostic Value; Drug Dose Escalation; Drug Dose Increase; Drug
Efficacy; Drug Safety; Drug Tolerance; Female; Forced Expiratory Volume; Gastrointestinal
Symptom/ Dt [Drug Therapy]; Gastrointestinal Symptom/ Si [Side Effect]; Human; Larynx Spasm/
Si [Side Effect]; Lung Disease/ Si [Side Effect]; Major Clinical Study; Male; Nose; Peak Nasal
Inspiratory Flow; Priority Journal; Repeated Drug Dose; Skin Disease/ Si [Side Effect]; Spirometry;
Symptom; Treatment Duration; *Acetylsalicylic Acid/ Ae [Adverse Drug Reaction];
*Acetylsalicylic Acid / Cb [Drug Combination]; *Acetylsalicylic Acid/ Do [Drug Dose];
*Acetylsalicylic Acid/ Dt [Drug Therapy]; *Acetylsalicylic Acid/ Na [Intranasal Drug
Administration]; *Acetylsalicylic Acid/ Po [Oral Drug Administration]; Adrenalin/ Dt [Drug
Therapy]; Antacid Agent/ Dt [Drug Therapy]; Antiemetic Agent/ Dt [Drug Therapy]; Antihistaminic
Agent/ Dt [Drug Therapy]; Beta 2 Adrenergic Receptor Stimulating Agent/ Dt [Drug Therapy];
Bronchodilating Agent/ Dt [Drug Therapy]; Corticosteroid/ Ad [Drug Administration];
Corticosteroid/ Dt [Drug Therapy]; Corticosteroid/ Ih [Inhalational Drug Administration];
Corticosteroid/ Na [Intranasal Drug Administration]; Decongestive Agent/ Dt [Drug Therapy];
*Ketorolac/ Ae [Adverse Drug Reaction]; *Ketorolac/ Cb [Drug Combination]; *Ketorolac/ Do
[Drug Dose]; *Ketorolac/ Dt [Drug Therapy]; *Ketorolac/ Na [Intranasal Drug Administration];
Leukotriene Receptor Blocking Agent/ Dt [Drug Therapy]; Long Acting Beta 2 Adrenergic Receptor
Agonist/ Cb [Drug Combination]; Long Acting Beta 2 Adrenergic Receptor Agonist/ Dt [Drug
Therapy]; Long Acting Beta 2 Adrenergic Receptor Agonist/ Ih [Inhalational Drug; Administration];
Montelukast/ Dt [Drug Therapy]; Nasacort Aq; Proton Pump Inhibitor/ Dt [Drug Therapy];
Ranitidine/ Dt [Drug Therapy]; Ranitidine/ Iv [Intravenous Drug Administration]; Steroid/ Cb [Drug
Combination]; Steroid/ Dt [Drug Therapy]; Steroid/ Ih [Inhalational Drug Administration];
Triamcinolone Acetonide/ Dt [Drug Therapy]; Triamcinolone Acetonide/ Ih [Inhalational Drug
Administration]; Unclassified Drug; Zafirlukast/ Dt [Drug Therapy]; Zileuton/ Dt [Drug Therapy]
Notes: Publication Type: Journal: Article
Abstract: Background: Intranasal ketorolac challenges can induce respiratory reactions in patients
with aspirin-exacerbated respiratory disease (AERD). Objective: To determine whether intranasal
ketorolac challenges might be used for aspirin desensitization. Methods: One hundred patients with
suspected AERD who were referred to Scripps Clinic from May 1, 2007 to December 31, 2009 were
challenged with 4 increasing doses of ketorolac intranasally at 30-minute intervals. Symptoms,
objective changes in the results of their nasal examination, peak nasal inspiratory flow rates, and
forced expiratory volume in 1 second (FEV<sub>1</sub>) values were recorded. After nasal
ketorolac dosing, patients were given oral aspirin as part of the challenge and desensitization. A
control group consisted of 100 patients who had previously undergone our standard oral aspirin
challenges and desensitization. Both groups were consecutively enrolled and had similar clinical
characteristics. Results: Compared with the standard oral aspirin challenge and desensitization,
intranasal ketorolac and modified aspirin challenge significantly attenuated the mean percentage
decrease in FEV<sub>1</sub> values (8.5% vs 13.4%; P = .01) and decreased the percentage of
extrapulmonary reactions (23% vs 45%; P = .002), particularly laryngospasm (7% vs19%; P = .02)
and gastrointestinal reactions (12% vs 33%; P = .001). This new protocol was significantly shorter,
lasting an average of 1.9 vs 2.6 days (P = <.001). In fact, 83% of the patients completed the new
protocol in less than 48 hours compared with only 20% in the oral challenge control group (P <
.001). Conclusions: Intranasal ketorolac challenge and desensitization followed by rapid oral aspirin
challenges is effective, safe, and less time-consuming than our standard oral aspirin desensitization
protocol. 2010 American College of Allergy, Asthma & Immunology
28. Leonardi S, Arena A, Bruno ME, Cannao PM , D'Anneo RW, Falagiani P, Gammeri E, Mistrello G, Nicolini
A, Ricciardi L, et al. (M. E. Bruno, Medical Service, Lofarma S.p.A, Viale Cassala 40, 20143 Milan,
Italy. E-mail: [email protected]). Olea sublingual allergoid immunotherapy administered with
two different treatment regimens. 2010221384, English. Allergy and Asthma Proceedings 2010;
31(2):e25-e29.
Keywords: AIRWAYS ID: AST/ Adult; *Allergic Rhinitis / Dt [Drug Therapy]; Article; Asthma/ Dt
[Drug Therapy]; Clinical Article; Clinical Trial; Controlled Clinical Trial; Controlled Study; Drug
Efficacy; Drug Safety; Drug Use; Female; Human; *Immunotherapy; Male; *Olive Tree; Patient
Assessment; Randomized Controlled Trial; Sensitization; Statistical Significance; *Sublingual
Immunotherapy; Treatment Duration; Visual Analog Scale; Wellbeing; Cetirizine / Dt [Drug
Therapy]; Fluticasone Propionate/ Dt [Drug Therapy]; Fluticasone Propionate/ Na [Intranasal Drug
Administration]; *Immunomodulating Agent/ Ct [Clinical Trial]; *Immunomodulating Agent/ Dt
[Drug Therapy]; *Immunomodulating Agent/ Li [Sublingual Drug Administration]; Lais;
Loratadine/ Dt [Drug Therapy]; Salbutamol/ Dt [Drug Therapy]; Salbutamol/ Ih [Inhalational Drug
Administration]; Salmeterol/ Dt [Drug Therapy]; Unclassified Drug
Notes: Publication Type: Journal: Article
Abstract: Sublingual immunotherapy (SLIT) with monomeric carbamylated allergoid administered
in accordance with the standard regimen has proven to be effective and safe. Achieving clinical
benefit, however, requires a lengthy period of time so it is not very suitable for short-lasting
allergies. We thus performed this study to compare an administration protocol starting in the
coseasonal period (with a 4-day build-up phase) with a precoseasonal scheme to verify if the former
regimen provides the same benefit in a shorter period of time. The prospective, randomized, drug
therapy-controlled study was conducted in 33 rhinitic patients monosensitized to Olea with or
without asthma. Ten patients were assigned to the coseasonal therapy with 5000 allergic units
(AU)/week for 6 weeks, 11 to the precoseasonal therapy with 3000 AU/week for 10 weeks, and 12
to drug therapy. They were treated from April or May to June 2008. A visual analog scale (VAS)
was performed at baseline and after treatment to assess the well being of the patients. Drug
consumption was evaluated by means of a monthly diary. There was greater VAS improvement in
both the SLIT groups versus the controls, but it was statistically significant only in the coseasonal
group (p < 0.01). Furthermore, there was a reduction in the rescue medication only in the coseasonal
SLIT (p < 0.05 versus drug therapy). One mild adverse event was observed. The allergoid SLIT was
shown to be effective and safe in Olea allergy in particular when a coseasonal regimen was used.
Copyright copyright 2010, OceanSide Publications, Inc., U.S.A
29. Ma X-P, Duolikun (X.-P. Ma, Department of Pediatrics, First Affiliated Hospital, Xinjiang Medical
University, Urumqi 830054, China. E-mail: [email protected]). Efficacy of sublingual
immunotherapy in children with dust mite allergic asthma. 2010326089, Chinese. Chinese Journal of
Contemporary Pediatrics 2010; 12(5 ):344-7.
Keywords: AIRWAYS ID: AST/ *Allergic Asthma/ Dt [Drug Therapy]; Article; Clinical Article;
*Dermatophagoides Pteronyssinus; Follow up; Forced Expiratory Volume; Human;
*Immunotherapy; Lung Function Test; Prick Test; Scoring System; Visual Analog Scale;
*Corticosteroid/ Dt [Drug Therapy]; *Corticosteroid/ Ih [Inhalational Drug Administration];
Immunoglobulin E/ Ec [Endogenous Compound]
Notes: Publication Type: Journal: Article
Abstract: Objective: To compare the efficacy of sublingual immunotherapy (SLIT) combined with
inhaled corticosteroids (ICS) versus ICS alone in children with mild and moderate dust mite allergic
asthma. Methods: Thirty-two children with mild and moderate dust mite allergic asthma were
randomly divided into two groups: SLIT + ICS ( n = 18) and ICS alone (n = 14). A total of 30
children completed the one year clinical observation . The amount of ICS administration, the day
and night symptom scores, skin-prick test and pulmonary function test results, serum specific
immunoglobulin E (sIgE) and G4 (sIgG4) levels and visual analog scale (VAS) scores were
compared between the two groups. Results: By the end of one year the SLIT + ICS group had
significantly decreased amount of ICS administration than the ICS alone group. Compared with the
ICS alone group, the day and night symptom scores decreased, FEF25-75% increased significantly,
and serum sIgE levels and VAS scores were significantly reduced in the SLIT + ICS group. There
were no statistical differences in the skin-prick test results, and FEV1 and sIgG4 levels between the
two groups. No severe adverse events occurred in both groups during the follow-up period.
Conclusions: SLIT combined with ICS may produce a better efficacy than ICS alone in the
improvement of day and night symptoms, pulmonary function and VAS scores in children with dust
mite-allergic asthma
30. Majak P, Rychlik B, Pulaski L, Blauz A, Agnieszka B, Bobrowska-Korzeniowska M, Kuna P, Stelmach I (I.
Stelmach, Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland. E-mail:
[email protected]). Montelukast treatment may alter the early efficacy of immunotherapy in
children with asthma. 2010296105, English. Journal of Allergy and Clinical Immunology 2010;
125(6):1220-7.
Keywords: AIRWAYS ID: AST/ Article; *Asthma/ Dt [Drug Therapy]; Bedtime Dosage; Child;
Clinical Article; Clinical Protocol; Clinical Trial; Controlled Clinical Trial; Controlled Study;
Double Blind Procedure; Drug Dose Reduction; Drug Efficacy; Female; House Dust Allergy;
Human; *Immunotherapy; Male; Priority Journal; Randomized Controlled Trial; Regulatory T
Lymphocyte; Symptom; Treatment Duration; Unspecified Side Effect/ Si [Side Effect]; Budesonide/
Do [Drug Dose]; Budesonide/ Dt [Drug Therapy]; Budesonide/ Ih [Inhalational Drug
Administration]; Corticosteroid/ Cb [Drug Combination]; Corticosteroid/ Dt [Drug Therapy];
Corticosteroid/ Ih [Inhalational Drug Administration]; *Montelukast/ Ae [Adverse Drug Reaction];
*Montelukast/ Ct [Clinical Trial]; *Montelukast/ Cb [Drug Combination]; *Montelukast/ Dt [Drug
Therapy]; *Montelukast/ Po [Oral Drug Administration]; Placebo
Notes: Publication Type: Journal: Article
Abstract: Background: Allergen-specific immunotherapy (SIT) is the only available potentially
curative approach in the management of allergic diseases. Therapies that boost regulatory T cell
induction during SIT might further enhance its effectiveness. Objective: The purpose of this study
was to assess the effect of montelukast treatment on early clinical and immunologic effects of
allergen-specific immunotherapy in children with asthma. Methods: It was a randomized,
double-blind, placebo-controlled trial conducted in 36 children with asthma and allergy to house dust
mites who required from 400 to 800 mug of inhaled budesonide per day during the 7-month run-in
period. Patients were randomly allocated to receive 5 mg montelukast daily (n = 18) or placebo (n =
18) as an addition to inhaled corticosteroid (ICS) treatment during the 3-month build-up phase of
SIT, when modification of ICS doses was not allowed. During the 7 months of the maintenance
phase of SIT, ICS doses were adjusted to control the asthma symptoms. Results: After 12 months of
SIT, a reduction of the median daily ICS dose, necessary to control asthma symptoms, was 16.7%
grater in patients from the placebo group than in patients from the montelukast group. Intervention
with montelukast significantly impaired the induction of regulatory T lymphocytes. During the
build-up phase of SIT, patients in the placebo group frequently experienced an increase in asthma
symptoms leading to exclusions from the per protocol population. Conclusion: Our study failed to
show a beneficial effect of montelukast on SIT. In fact, quite the opposite occurred: compared with
placebo, montelukast intervention led to less effectiveness of SIT. copyright 2010 American
Academy of Allergy, Asthma & Immunology
31. Majak P, Rychlik B, Stelmach I (I. Stelmach, Department of Pediatrics and Allergy, N. Copernicus Hospital,
62 Pabianicka Str. 93-513, Lodz, Poland. E-mail: [email protected]). The effect of oral
steroids with and without vitamin D3 on early efficacy of immunotherapy in asthmatic children.
2009656022, English . Clinical and Experimental Allergy 2009;39(12 ):1830-41.
Keywords: AIRWAYS ID: AST/ Article; *Asthma/ Dt [Drug Therapy]; Child; Clinical Assessment;
Clinical Trial; Controlled Clinical Trial; Controlled Study; Dermatophagoides; Double Blind
Procedure; Drug Efficacy; Drug Megadose; Drug Withdrawal; Female; Human; *Immunotherapy;
Major Clinical Study; Male; Outcome Assessment; Preschool Child; Priority Journal; Randomized
Controlled Trial; Regulatory T Lymphocyte; School Child; Single Drug Dose; Treatment Outcome;
Treatment Withdrawal; *Budesonide/ Ct [Clinical Trial]; *Budesonide/ Do [Drug Dose];
*Budesonide/ Dt [Drug Therapy]; *Budesonide/ Ih [Inhalational Drug Administration];
*Colecalciferol/ Ct [Clinical Trial]; *Colecalciferol/ Cb [Drug Combination]; *Colecalciferol/ Do
[Drug Dose]; *Colecalciferol/ Dt [Drug Therapy]; Placebo; *Prednisone/ Ct [Clinical Trial];
*Prednisone/ Cb [Drug Combination]; *Prednisone/ Dt [Drug Therapy]; *Prednisone/ Po [Oral Drug
Administration]; Unclassified Drug; Vigantoletten 1000
Notes: Publication Type: Journal: Article
Abstract: Background The possibility of additional strategies to enhance the effectiveness of specific
immunotherapy (SIT) is highly attractive. Aim The aim of our study was to assess the influence of
oral corticosteroids and oral corticosteroids combined with vitamin D3 on the early clinical and
immunological effects of SIT. Methods It was a randomized, double-blind, placebo-controlled trial
conducted in 54 asthmatic children allergic to house dust mites. Intervention was based on receiving
a single dose of oral steroid, with or without vitamin D3, or placebo only on the day of the build-up
phase of SIT. Results After 12 months of SIT, the median daily inhaled corticosteroid (ICS) dose,
which controls the symptoms of asthma, was reduced by 25% in the steroid group. However, a 50%
reduction of the median daily ICS dose was observed in the control group. The clinical effects of SIT
were not affected in the steroid+D3 group. Concomitantly, we found that intervention with
prednisone significantly impaired the induction of T regulatory lymphocytes. Importantly, the
clinical and immunological effects of SIT were not affected by intervention with steroids
administered with vitamin D3. Conclusions Our study failed to show a beneficial effect of oral
corticosteroids on allergen-specific immunotherapy. We observed that the combined administration
of a corticosteroid drug and allergen extract suppressed the early clinical and immunological effects
of SIT and that vitamin D 3 prevented this 'adverse' influence of steroids. copyright 2009 Blackwell
Publishing Ltd
32. Majak P, Stelmach P, Brzozowska A, Stelmach I. [Safety of accelerated immunotherapy build-up schedule
with Phostal in asthmatic children allergic to house dust mite] [Ocena bezpieczenstwa skrocenia fazy
wstepnej immunoterapii alergenowej preparatem Phostal u dzieci uczulonych na roztocze kurzu
domowego, chorych na astme oskrzelowa.]. CN-00641728, EMBASE 2007074363. Alergia Astma
Immunologia 2006;11(4):207-10.
Keywords: AIRWAYS ID: AST/ Article; *Asthma; Dt [Drug Therapy]; Child; Clinical Trial;
Controlled Clinical Trial; Controlled Study; Drug Effect; Drug Safety; House Dust Allergy; Human;
Immunotherapy; Major Clinical Study; Randomized Controlled Trial; Budesonide; Ct [Clinical
Trial]; Budesonide; Dt [Drug Therapy]; *Immunomodulating Agent; Ct [Clinical Trial];
*Immunomodulating Agent; Dt [Drug Therapy]; *Immunomodulating Agent; Sc [Subcutaneous
Drug Administration]; Salbutamol; Ct [Clinical Trial]; Salbutamol; Dt [Drug Therapy]
Notes: Publication Type: Journal: Article
Abstract: Introduction. Accelerated immunotherapy build-up schedules offer the advantage of
reduced number of office visits and cause that the procedure is better tolerated by patients and their
carers. Aim of the study. The aim of this study was to investigate the safety of accelerated
immunotherapy build-up schedule with Phostal in children with asthma, allergic to house dust mite
Material and methods. In the randomized control study we compared safety of standard (14 week)
and accelerated (9 week) build-up schedule of immunotherapy in 100 asthmatic children allergic to
house dust mite. Results. Ninety nine children were finally enlisted in the study (one child was
excluded due to asthma exacerbation). Subcutaneus immunotherapy administered using an
accelerated (n=50) and a standard (n=49) protocol was equally safe. There were no differences in
local or serious adverse reactions between the study groups. Conclusion. Accelerated (9-week)
schedule used instead of the standard (14-week) build-up schedule of immunotherapy with Phostal
did not increase the frequency of adverse effects in asthmatic children allergic to house dust mite.
copyright Alergia Astma Immunologia, 2006. Copyright © 2008 Elsevier B. V., Amsterdam. All
Rights Reserved.
33. Marappan M. Changes in clinical status and serum IGE levels following sublingual immunotherapy for 2
years in patients with allergic rhinitis and/or asthma due to house dust mite [Abstract]. Chest
2008;134(4):43001s.
Keywords: AIRWAYS ID: AST/ asthma; allergic rhinitis
Abstract: CHEST 2008 Annual Meeting Abstracts
34. Marogna M, Colombo F, Spadolini I, Massolo A, Berra D, Zanon P, Chiodini E, Canonica GW, Passalacqua
G (Pneumology Unit, Cuasso al Monte, Macchi Hospital Foundation, Varese, Italy.). Randomized
open comparison of montelukast and sublingual immunotherapy as add-on treatment in moderate
persistent asthma due to birch pollen., English. Journal of Investigational Allergology & Clinical
Immunology 2010;20(2):146-52.
Keywords: AIRWAYS ID: AST/ *Acetates/ ad [Administration & Dosage]/ Acetates/ ae [Adverse
Effects]/ Administration, Sublingual/ Adolescent/ Adult/ Aged/ Antigens, Plant/ ad [Administration
& Dosage]/ Antigens, Plant/ ae [Adverse Effects]/ Antigens, Plant/ im [Immunology]/ Asthma/ et
[Etiology]/ Asthma/ im [Immunology]/ Asthma/ pp [Physiopathology]/ *Asthma/ th [Therapy]/
Betula/ im [Immunology]/ Cell Count/ *Desensitization, Immunologic/ Disease Progression/
Eosinophilia/ Female/ Follow-Up Studies/ Humans/ *Leukotriene Antagonists/ ad [Administration
& Dosage]/ Leukotriene Antagonists/ ae [Adverse Effects]/ Male/ Middle Aged/ Nasal Obstruction/
*Quinolines/ ad [Administration & Dosage]/ Quinolines/ ae [Adverse Effects]/ Rhinitis, Allergic,
Seasonal/ co [Complications]/ Rhinitis, Allergic, Seasonal/ im [Immunology]/ Rhinitis, Allergic,
Seasonal/ pp [Physiopathology]/ *Rhinitis, Allergic, Seasonal/ th [Therapy]
Notes: PUBLICATION TYPE: Comparative Study
PUBLICATION TYPE: Journal Article
PUBLICATION TYPE: Randomized Controlled Trial
Abstract: BACKGROUND: No studies have directly compared the effects of immunotherapy and
antileukotrienes due to the long time required to appreciate the clinical effects of immunotherapy.
We compared the effect of montelukast (MK) and SLIT added to standard therapy in moderate
asthma over 5 years. METHODS: Open randomized controlled trial. Patients with moderate asthma
(and rhinitis) solely due to birch pollen were randomized to receive either MK (10 mg/d) or birch
sublingual immunotherapy (SLIT) in the pollen seasons, in addition to formoterol/fluticasone. All
the patients also received salbutamol and cetirizine as rescue medications. Asthma and rhinitis
symptoms were recorded on diary cards from February to May at baseline and after 3 and 5 years of
study. In-season nasal eosinophils and bronchial hyperresponsiveness were also evaluated.
RESULTS: Thirty-three adult patients were enrolled and 29 completed the study. The groups were
homogeneous at baseline. Bronchial and nasal symptom scores were lower at 3 and 5 years
compared to baseline in the SLIT group. Bronchial hyperresponsiveness and bronchodilator use
decreased significantly in both groups at 5 years, but only in the SLIT group at 3 years. In the SLIT
group there was a significant decrease in nasal eosinophils compared to baseline and to the MK
group. CONCLUSION: In patients with birch pollen-induced moderate asthma and rhinitis, the
addition of SLIT provides a greater clinical benefit than that of MK.
35. Marogna M, Spadolini I, Massolo A, Berra D, Zanon P, Chiodini E, Canonica GW, Passalacqua G
(Pneumology Unit, Macchi Hospital Foundation, Cuasso al Monte, Varese, Italy.). Long-term
comparison of sublingual immunotherapy vs inhaled budesonide in patients with mild persistent
asthma due to grass pollen. Annals of Allergy, Asthma, & Immunology 2009;102(1):69-75.
Keywords: AIRWAYS ID: AST/ Administration, Inhalation/ Administration, Sublingual/
Adolescent/ Adult/ Allergens/ ad [Administration & Dosage]/ Allergens/ tu [Therapeutic Use]/
Anti-Inflammatory Agents/ ad [Administration & Dosage]/ *Anti-Inflammatory Agents/ tu
[Therapeutic Use]/ Asthma/ dt [Drug Therapy]/ Asthma/ im [Immunology]/ *Asthma/ th [Therapy]/
Budesonide/ ad [Administration & Dosage]/ *Budesonide/ tu [Therapeutic Use]/ *Desensitization,
Immunologic/ Female/ Follow-Up Studies/ Humans/ Male/ Poaceae/ im [Immunology]/ Pollen/ im
[Immunology]/ Rhinitis, Allergic, Seasonal/ dt [Drug Therapy]/ Rhinitis, Allergic, Seasonal/ im
[Immunology]/ *Rhinitis, Allergic, Seasonal/ th [Therapy]/ Young Adult
Notes: PUBLICATION TYPE: Comparative Study
PUBLICATION TYPE: Journal Article
PUBLICATION TYPE: Randomized Controlled Trial
Abstract: BACKGROUND: Few studies have compared the effects of immunotherapy and inhaled
steroids. The main limitation of such studies is the long duration required to fully appreciate the
effects of immunotherapy. OBJECTIVE: To compare the effects of inhaled budesonide and
sublingual immunotherapy (SLIT) in mild persistent asthma for up to 5 years. METHODS: Patients
with mild persistent asthma and rhinitis due to grass pollen were enrolled in an open randomized
controlled trial. After a run-in season, they were randomized to either budesonide, 800 microg/d, in
the pollen season or continuous grass SLIT for 5 years. All patients received rescue medications.
Symptoms were evaluated by diary cards filled out from May to July at baseline and after 3 and 5
years. In-season nasal eosinophils and bronchial hyperresponsiveness were also assessed.
RESULTS: Fifty-one patients were enrolled and 46 completed the study. The bronchial symptom
scores and the use of bronchodilators decreased significantly in both groups, but the improvement
was greater in the SLIT patients at 3 and 5 years. The nasal symptom score and the intake of nasal
steroids decreased only in the SLIT group, and the difference vs the budesonide group was always
significant. In the SLIT group vs the budesonide group, a statistically significant decrease of nasal
eosinophils was found at 3 and 5 years (P < .01). The bronchial hyperresponsiveness improved
significantly only in the SLIT group. CONCLUSION: In patients with grass pollen-induced asthma,
in the long term SLIT was equally effective as inhaled budesonide in treating bronchial symptoms
and provided an additional benefit in treating rhinitis symptoms and bronchial hyperresponsiveness.
36. Marogna M, Tomassetti D, Bernasconi A, Colombo F, Massolo A, Businco AD, Canonica GW, Passalacqua
G, Tripodi S (Pneumology Unit, Cuasso al Monte, Macchi Hospital Foundation, Varese, Italy.).
Preventive effects of sublingual immunotherapy in childhood: an open randomized controlled study.
Annals of Allergy, Asthma, & Immunology 2008;101(2):206-11.
Keywords: AIRWAYS ID: AST/ Administration, Sublingual/ Asthma/ im [Immunology]/ *Asthma/
pc [Prevention & Control]/ Asthma/ th [Therapy]/ *Bronchial Hyperreactivity/ pc [Prevention &
Control]/ Bronchial Hyperreactivity / th [Therapy]/ Child/ *Desensitization, Immunologic/ Female/
Humans/ Male/ Rhinitis, Allergic, Perennial/ im [Immunology]/ *Rhinitis, Allergic, Perennial/ pc
[Prevention & Control]/ Rhinitis, Allergic, Perennial/ th [Therapy]
Notes: PUBLICATION TYPE: Journal Article
PUBLICATION TYPE: Randomized Controlled Trial
Abstract: BACKGROUND: Sublingual immunotherapy (SLIT) has been proved to be effective in
allergic rhinitis and asthma, but there are few data on its preventive effects, especially in children.
OBJECTIVE: To evaluate the clinical and preventive effects of SLIT in children by assessing onset
of persistent asthma and new sensitizations, clinical symptoms, and bronchial hyperreactivity.
METHODS: A total of 216 children with allergic rhinitis, with or without intermittent asthma, were
evaluated and then randomized to receive drugs alone or drugs plus SLIT openly for 3 years. The
clinical score was assessed yearly during allergen exposure. Pulmonary function testing,
methacholine challenge, and skin prick testing were performed at the beginning and end of the study.
RESULTS: One hundred forty-four children received SLIT and 72 received drugs only. Dropouts
were 9.7% in the SLIT group and 8.3% in the controls. New sensitizations appeared in 34.8% of
controls and in 3.1% of SLIT patients (odds ratio, 16.85; 95% confidence interval, 5.73-49.13). Mild
persistent asthma was less frequent in SLIT patients (odds ratio, 0.04; 95% confidence interval,
0.01-0.17). There was a significant decrease in clinical scores in the SLIT group vs the control group
since the first year. The number of children with a positive methacholine challenge result decreased
significantly after 3 years only in the SLIT group. Adherence was 80% or higher in 73.8% of
patients. Only 1 patient reported systemic itching. CONCLUSIONS: In everyday clinical practice,
SLIT reduced the onset of new sensitizations and mild persistent asthma and decreased bronchial
hyperreactivity in children with respiratory allergy.
37. Massanari M, Nelson H, Casale T, Busse W, Kianifard F, Geba GP, Zeldin RK (M. Massanari, Novartis
Pharmaceuticals Corp, East Hanover, NJ, United States. E-mail: [email protected]).
Effect of pretreatment with omalizumab on the tolerability of specific immunotherapy in allergic
asthma. 2010087294, English. Journal of Allergy and Clinical Immunology 2010;125(2):383-9.
Keywords: AIRWAYS ID: AST/ Adult; *Allergic Asthma/ Dt [Drug Therapy]; Allergic Reaction/
Si [Side Effect]; Anaphylaxis/ Si [Side Effect]; Angina Pectoris/ Si [Side Effect]; Angioneurotic
Edema/ Si [Side Effect]; Article; Asthma/ Si [Side Effect]; Cat; Cellulitis/ Si [Side Effect]; Chest
Tightness/ Si [Side Effect]; Clinical Trial; Collapse/ Si [Side Effect]; Control Group; Controlled
Clinical Trial; Controlled Study; Coughing / Si [Side Effect]; Cyanosis/ Si [Side Effect]; Dizziness/
Si [Side Effect]; Dog; Double Blind Procedure; Drug Efficacy; Drug Tolerability; Drug Withdrawal;
Dyspnea/ Si [Side Effect]; Erythema/ Si [Side Effect]; Female; Heart Arrhythmia/ Si [Side Effect];
Hoarseness/ Si [Side Effect]; Human; Hypotension/ Si [Side Effect]; *Immunotherapy; Induced
Abortion; Injection Site Erythema/ Si [Side Effect]; Injection Site Pruritus/ Si [Side Effect];
Injection Site Reaction/ Si [Side Effect]; Maintenance Therapy; Major Clinical Study; Male; Mantel
Haenszel Test; Multicenter Study; Nausea/ Si [Side Effect]; Nose Disease/ Si [Side Effect];
Outcome Assessment; Priority Journal; Pruritus/ Si [Side Effect]; Randomized Controlled Trial;
Rectum Carcinoma/ Si [Side Effect]; Sexual Abuse; Side Effect/ Si [Side Effect]; Sinusitis/ Si [Side
Effect]; Spinal Cord Tumor / Si [Side Effect]; Stomach Pain/ Si [Side Effect]; Stridor/ Si [Side
Effect]; Treatment Duration; Urticaria/ Si [Side Effect]; Vomiting/ Si [Side Effect]; Wheezing/ Si
[Side Effect]; Adrenalin/ Ct [Clinical Trial]; Adrenalin/ Dt [Drug Therapy]; Antihistaminic Agent/
Ct [Clinical Trial]; Antihistaminic Agent/ Dt [Drug Therapy]; Beta Adrenergic Receptor Stimulating
Agent/ Ct [Clinical Trial]; Beta Adrenergic Receptor Stimulating Agent/ Dt [Drug Therapy];
Corticosteroid/ Ct [Clinical Trial]; Corticosteroid/ Dt [Drug Therapy]; Corticosteroid/ Ih
[Inhalational Drug Administration]; House Dust Allergen; *Omalizumab/ Ae [Adverse Drug
Reaction]; *Omalizumab/ Ct [Clinical Trial]; *Omalizumab/ Dt [Drug Therapy]; *Omalizumab/ Sc
[Subcutaneous Drug Administration]; Placebo; Steroid/ Ct [Clinical Trial]; Steroid/ Dt [Drug
Therapy]; Steroid/ Po [Oral Drug Administration]
Notes: Publication Type: Journal: Article
Abstract: Background: Although specific immunotherapy is a valuable treatment option for patients
with allergic asthma, the potential for systemic allergic reactions has limited its use, especially for
patients with symptomatic disease. Objective: To evaluate omalizumab's effect on the tolerability of
specific immunotherapy in patients with symptomatic persistent asthma not adequately controlled
with inhaled corticosteroids. Methods: This multicenter, double-blind, parallel-group study
randomized patients to treatment with omalizumab or placebo, after which they received specific
immunotherapy to at least 1 of 3 perennial aeroallergens (cat, dog, and house dust mite) according to
a 4-week, 18-injection cluster regimen, followed by 7 weeks of maintenance therapy. The primary
efficacy variable, a systemic allergic reaction after immunotherapy, was analyzed by using the
Cochrane-Mantel-Haenszel test. Results: A total of 248 randomized patients (126 omalizumab, 122
placebo) received at least 1 dose of immunotherapy and were evaluated for efficacy. Patients
receiving omalizumab experienced significantly fewer systemic allergic reactions to immunotherapy
than those receiving placebo (17/126 [13.5%] vs 32/122 [26.2%]; P = .017; 95% CI, 2.91% to
22.56%) and had fewer respiratory-related (grade 3) systemic allergic reactions (6 vs 24,
respectively). Grade 4 reactions were reported in 2 patients in each group. More omalizumab
patients were able to reach the target maintenance immunotherapy dose (110 [87.3%] vs 88 [72.1%],
respectively; P = .004). Conclusion: Use of omalizumab in patients whose asthma was symptomatic
despite use of inhaled corticosteroids was associated with fewer systemic allergic reactions to
specific immunotherapy and enabled more patients to achieve the target immunotherapy
maintenance dose. copyright 2010 American Academy of Allergy, Asthma & Immunology
38. Nasser S, Vestenbaek U, Beriot-Mathiot A, Poulsen PB. Cost-effectiveness of specific immunotherapy with
Grazax in allergic rhinitis co-existing with asthma. 2008540188. Allergy: European Journal of
Allergy and Clinical Immunology 2008;63(12):1624-9.
Keywords: AIRWAYS ID: AST/ *Allergic Rhinitis/ Dm [Disease Management]; *Allergic Rhinitis/
Dt [Drug Therapy]; Article; *Asthma/ Dm [Disease Management]; *Asthma/ Dt [Drug Therapy];
Clinical Trial; Comorbidity; Controlled Clinical Trial; Controlled Study; *Cost Effectiveness
Analysis; Disease Association; Double Blind Procedure; Drug Cost; Drug Efficacy; Grass Pollen;
Human; Immunotherapy; Major Clinical Study; Priority Journal; Quality of Life; Randomized
Controlled Trial; Rhinoconjunctivitis/ Dt [Drug Therapy]; Rhinoconjunctivitis/ Et [Etiology];
Sensitivity Analysis; Treatment Outcome; United Kingdom; Budesonide/ Dt [Drug Therapy];
Budesonide/ Ih [Inhalational Drug Administration]; Budesonide/ Pe [Pharmacoeconomics];
Desloratadine/ Dt [Drug Therapy]; Desloratadine/ Po [Oral Drug Administration]; Desloratadine/ Pe
[Pharmacoeconomics]; Fluticasone/ Dt [Drug Therapy]; Fluticasone/ Pe [Pharmacoeconomics];
*Grazax/ Ct [Clinical Trial]; *Grazax/ Dt [Drug Therapy]; *Grazax/ Po [Oral Drug Administration];
*Grazax/ Pe [Pharmacoeconomics]; *Immunomodulating Agent/ Ct [Clinical Trial];
*Immunomodulating Agent/ Dt [Drug Therapy]; *Immunomodulating Agent/ Po [Oral Drug
Administration]; *Immunomodulating Agent/ Pe [Pharmacoeconomics]; Placebo; Salbutamol/ Dt
[Drug Therapy]; Salbutamol/ Ih [Inhalational Drug Administration]; Salbutamol/ Pe
[Pharmacoeconomics]; Unclassified Drug
Abstract: Background: In the United Kingdom, approximately 10.8 million people suffer from
asthma, placing an economic burden on the society of more than [pounds]2 billion per year. For
allergic asthma, treatment options consist of allergen avoidance, symptomatic treatment and
allergen-specific immunotherapy (SIT). Only SIT addresses the underlying cause of the disease,
reducing symptoms and offering the potential for long-term improvement. Grazax - the first
tablet-based SIT - is indicated for the treatment of patients with grass pollen-induced
rhinoconjunctivitis, including those with co-existing asthma. Objective: To assess the
cost-effectiveness of Grazax in patients with rhinoconjunctivitis and co-existing asthma. Methods: A
prospective pharmacoeconomic analysis was carried out as part of a multinational clinical trial
assessing the efficacy of Grazax (n = 79) compared with placebo (n = 72). Both groups had access to
symptomatic medication; thus the placebo group represented current standard care. Pooled data on
health resource use, productivity loss because of absence from work and quality of life (Quality
Adjusted Life Years, QALYs) were collected in the trial. Reduced productivity at work was
estimated from the literature. A societal perspective was adopted with a 9-year time horizon. The
NHS price of Grazax of [pounds]2.25 per tablet was used. Results: The QALY gain was
significantly higher for patients treated with Grazax than the placebo group receiving symptomatic
medication alone (0.197 discounted QALYs gained 9 years into the future - equal to an extra 72 days
of perfect health over 9 years). The levels of resource use and productivity loss were higher for the
placebo group. As a result, the cost per QALY gained with Grazax was [pounds]4319, which is
highly cost-effective. Price sensitivity analyses demonstrated that Grazax remained cost-effective up
to a tablet price of [pounds]5.07. Conclusion: SIT with Grazax is a cost-effective strategy compared
with standard management of patients with rhinoconjunctivitis and co-existing asthma. copyright
2008 The Authors. Drug Trade Names and Manufacturers grazax
39. Niggemann B, Nilsson M, Friedrichs F. Paediatric allergy diagnosis in primary care is improved by in vitro
allergen-specific IgE testing. 2008240964. Pediatric Allergy and Immunology 2008;19(4):325-31.
Keywords: AIRWAYS ID: AST/ *Allergy/ Di [Diagnosis]; *Allergy/ Dt [Drug Therapy]; Allergy
Test; Article; Asthma/ Dt [Drug Therapy]; Clinical Trial; Controlled Study; Eczema/ Dt [Drug
Therapy]; Female; Human; in Vitro Study; Infant; Male; Preschool Child; Primary Medical Care;
Priority Journal; Rhinitis/ Dt [Drug Therapy]; Wheezing/ Dt [Drug Therapy]; Allergen; Antibiotic
Agent/ Dt [Drug Therapy]; Antihistaminic Agent/ Dt [Drug Therapy]; Bronchodilating Agent/ Dt
[Drug Therapy]; Corticosteroid/ Dt [Drug Therapy]; Decongestive Agent/ Dt [Drug Therapy];
Immunoglobulin E/ Ec [Endogenous Compound]
Abstract: Allergy testing is an important pre-requisite for both early identification of infants at
increased risk for later development of allergic diseases and for specific allergy treatment including
specific allergen avoidance measures, pharmacotherapy and specific immunotherapy. The aim of
this study was to investigate the influence of in vitro allergen-specific immunoglobulin E (IgE)
testing on the primary care physician's diagnosis and clinical management of children with
symptoms of eczema, wheezing/asthma and rhinitis. The trial was a prospective study performed at
14 paediatric primary care practices in Germany, covering 380 children below 6 yr of age. For one
group of children the physician received the IgE test results as soon as possible and used them as an
additional tool when diagnosing and giving clinical management advice. For the other group of
children the IgE test results were not made available to the physician until the children were brought
to a second visit, about 7 wk later. When diagnosis was made without access to allergen-specific IgE
results, 8% of the children were diagnosed as allergic, 6% as non-allergic and in 86% of the cases
the physician was uncertain. With access to allergen-specific IgE results the figures were 13%, 65%
and 22%, respectively. Concerning clinical management advice no statistically significant
differences between the two study groups were observed. When comparing the first and second
visits of the patients coming for a second visit advice to reduce aeroallergen exposure was given to
27% of the patients at visit 1 and to 36% of the patients at visit 2 (p = 0.002). The difference
between the first and second visits of the other clinical management advice studied did not reach
statistical significance. In this study the availability of IgE test results to the primary care physician
had an impact on the decision-making process of the diagnosis but not on the pharmaceutical or
avoidance advice given. The reason why IgE test results were not fully exploited needs to be further
scrutinized. copyright 2008 The Authors.
40. O'Hehir RE, Gardner LM, de Leon MP, Hales BJ, Biondo M, Douglass JA, Rolland JM, Sandrini A
(Department of Allergy, Immunology and Respiratory Medicine, Alfred Hospital, Commercial
Road, Melbourne, VIC 3004, Australia. [email protected]). House dust mite
sublingual immunotherapy: the role for transforming growth factor-beta and functional regulatory T
cells., English. American Journal of Respiratory & Critical Care Medicine 2009 Nov
15;180(10):936-47.
Keywords: AIRWAYS ID: AST/ Administration, Sublingual/ Adolescent/ Adult/ Aged / Allergens/
ad [Administration & Dosage]/ Animals/ Asthma/ th [Therapy]/ Double-Blind Method/ Female/
Humans/ *Immunotherapy/ mt [Methods]/ Interleukin-5/ bi [Biosynthesis]/ Male/ Middle Aged/
*Pyroglyphidae/ im [Immunology]/ *Respiratory Hypersensitivity/ th [Therapy]/ Rhinitis, Allergic,
Perennial / th [Therapy]/ *T-Lymphocytes, Regulatory/ im [Immunology]/ *Transforming Growth
Factor beta/ ph [Physiology]
Notes: PUBLICATION TYPE: Journal Article
PUBLICATION TYPE: Randomized Controlled Trial
PUBLICATION TYPE: Research Support, Non-U.S. Gov't
Abstract: RATIONALE: Sublingual allergen-specific immunotherapy is gaining popularity for
treatment of allergic diseases, but underlying immunological mechanisms are unresolved.
OBJECTIVES: To perform detailed immunological investigation of sublingual house dust mite
(HDM) immunotherapy. METHODS: A 12-month randomized double-blind placebo-controlled
study of sublingual HDM immunotherapy in 30 HDM-allergic subjects was performed, with 1-year
open extension in 9 patients on active treatment. HDM-stimulated blood mononuclear cells were
analyzed for proliferation, cytokines, and regulatory T cells (Tregs) by flow cytometry and ELISA.
Effects of blocking transforming growth factor (TGF)-beta and IL-10 on proliferation were
determined. Treg suppressor function and allergen-specific antibody levels were measured. Clinical
efficacy was assessed by symptom, medication, and Juniper quality-of-life scores.
MEASUREMENTS AND MAIN RESULTS: Allergen-induced CD4(+) T-cell division and IL-5
production were significantly decreased after 6- and 12-months' active treatment but not placebo.
sTGF-betaRII blocked immunotherapy-induced suppression of allergen-specific T-cell proliferation,
maximal at 6 months. Decreased allergen-specific CD4(+) T-cell proliferation and increased IL-10
secretion and serum Der p 2-specific IgG(4) were maximal at 24 months' active treatment. Treg
(CD4(+)CD25(+)CD127(lo)/Foxp3(+)) function was demonstrated by suppression of
allergen-specific effector T-cell (CD4(+)CD25(-)CD127(hi)) proliferation and cytokine production.
Clinical efficacy of immunotherapy was supported by significantly decreased rhinitis symptom
score, total asthma score, and Juniper quality-of-life score. CONCLUSIONS: This study establishes
the novel finding that TGF-beta mediates the immunological suppression seen early in clinically
effective sublingual HDM immunotherapy in addition to an increase in Tregs with suppressor
function. Clinical trial registered with www.clinicaltrials.gov (NCT00250263).
41. Pfaar O, Klimek L, Fischer I, Sieber J , Amoroso S, Moreno Aguilar C, Shah K, Mosges R (Center for
Rhinology and Allergology Wiesbaden, Department of Otorhinolaryngology, Head and Neck
Surgery, University Hospital Mannheim, An den Quellen 10, Wiesbaden DE-65189, Germany.
[email protected]). Safety of two cluster schedules for subcutaneous immunotherapy
in allergic rhinitis or asthma patients sensitized to inhalant allergens., English. International Archives
of Allergy & Immunology 2009;150(1):102-8.
Keywords: AIRWAYS ID: AST/ Adolescent/ Adult/ *Allergens/ ad [Administration & Dosage]/
Allergens/ im [Immunology]/ Animals/ *Asthma/ pc [Prevention & Control]/ Desensitization,
Immunologic/ ae [Adverse Effects]/ *Desensitization, Immunologic/ mt [Methods]/ Female/
Humans/ Male/ Middle Aged/ Pollen/ im [Immunology]/ Pyroglyphidae/ im [Immunology]/
*Rhinitis, Allergic, Seasonal/ pc [Prevention & Control]/ Young Adult
Notes: PUBLICATION TYPE: Clinical Trial
PUBLICATION TYPE: Journal Article
PUBLICATION TYPE: Randomized Controlled Trial
Abstract: BACKGROUND: Subcutaneous immunotherapy (SCIT) usually requires a long titration
phase, which can be associated with various adverse events (AEs). OBJECTIVES: It was the aim of
this study to determine the safety of 2 cluster regimens for SCIT in patients with allergic rhinitis,
with or without mild or moderate allergic asthma, who were sensitized to grass and/or tree pollen, or
house dust mites (HDM). PATIENTS AND METHODS: Adult patients were included in a
European, open-label, prospective trial. Pollen-allergic patients received grass pollen, grass and olive
pollen, or hazel, alder and birch pollen according to a 3-week titration cluster. HDM-allergic patients
received HDM extract according to a 2-week titration cluster. The safety of the titration phase was
assessed in terms of local and systemic AEs. RESULTS: The safety analysis included 157 patients:
110 received pollen and 47 HDM extract. During the cluster titration, 248 AE episodes were
reported in the pollen group and 113 in the HDM group; these were mainly local reactions. Around
one third of patients (30.9% pollen and 38.3% HDM) did not experience any AE. In most cases
(67.1% of pollen and 71.1% of HDM patients), AEs did not lead to a change in titration schedule.
No anaphylactic reaction or other serious life-threatening systemic AEs were reported. Only 2
patients in the HDM group discontinued treatment because of AEs. CONCLUSIONS: Rapid cluster
titration was well tolerated in adults with allergic rhinitis, with or without mild to moderate allergic
asthma, due to pollen or HDM. This short-titration, high-dose cluster regime may allow better
patient compliance and cost savings. Copyright 2009 S. Karger AG, Basel.
42. Purohit A, Niederberger V, Kronqvist M, Horak F, Gronneberg R, Suck R, Weber B, Fiebig H, van Hage M,
Pauli G, et al. Clinical effects of immunotherapy with genetically modified recombinant birch pollen
Bet v 1 derivatives. CN-00643430. Clinical & Experimental Allergy 2008;38(9):1514-25.
Keywords: AIRWAYS ID: AST
Abstract: Background Birch pollen and pollen from related trees of the Fagales order are a major
cause of allergic rhinitis, conjunctivitis, and asthma through the spring season in northern and central
Europe. Objective To investigate the clinical effects of injection immunotherapy with genetically
modified derivatives of major birch pollen allergen Bet v 1 on pollen-induced allergic symptoms.
Methods A three-arm double-blind placebo-controlled immunotherapy study was conducted with
one pre-seasonal course of treatment using two derivatives of Bet v 1, namely a recombinant Bet v 1
trimer and an equimolar mixture of two recombinant Bet v 1 fragments together representing the
whole protein sequence. Analysis of local and systemic adverse events was performed for 124
patients who had received at least one dose of medication. Clinical efficacy was monitored by
symptom medication scores and interval scoring in the per protocol-treated population (n=84). In
addition, skin and nasal provocation responses and allergen-specific antibodies were assessed.
Results There were trends towards improvement in the subjects' well-being and clinical symptoms
(nasal scores), although comparisons with a placebo group did not show statistical significance in the
main end-point, the combined symptom medication score. Reductions in skin and nasal sensitivity
were observed for some subjects with a trend for the Bet v 1 trimer to be more effective than the
fragments. Treatment induced strong IgG1 and IgG4 allergen-specific antibody responses. Local
injection-site reactions were most frequent in the trimer group affecting 59.5% of patients as
opposed to 37.8% and 30.6% in the fragment and placebo groups, respectively. Systemic reactions
were elicited more frequently by fragments. A large proportion of adverse side-effects appeared
hours following injections, and might be attributable to concurrent exposure to related pollens.
Conclusion Single courses of injection immunotherapy with Bet v 1 allergen derivatives showed
trends towards improved well-being and reduced reactivity to specific allergen provocation, but did
not yield significant improvement in the combined symptom medication score in this study.
43. Rodriguez Santos O (Policlinico Universitario, Camaguey, Cuba. [email protected]). [Sublingual
immunotherapy in allergic rhinitis and asthma in 2-5 year-old children sensitized to mites]. [Spanish]
[Inmunoterapia sublingual en rinitis alergica y asma en ninos de dos a cinco anos sensibilizados con
acaros.], Spa . Revista Alergia Mexico 2008;55(2):71-5.
Keywords: AIRWAYS ID: AST/ Administration, Sublingual/ Adrenal Cortex Hormones/ tu
[Therapeutic Use]/ Allergens/ du [Diagnostic Use]/ *Allergens/ tu [Therapeutic Use] / Animals/
Anti-Allergic Agents/ tu [Therapeutic Use]/ Antigens, Dermatophagoides/ du [Diagnostic Use]/
Antigens, Dermatophagoides/ tu [Therapeutic Use]/ Asthma/ dt [Drug Therapy]/ Asthma/ et
[Etiology]/ *Asthma/ th [Therapy]/ Child, Preschool/ Combined Modality Therapy/
*Desensitization, Immunologic/ Emergency Service, Hospital/ ut [Utilization]/ Female/ Humans/
Male/ *Mites/ im [Immunology]/ Rhinitis, Allergic, Perennial/ dt [Drug Therapy]/ Rhinitis, Allergic,
Perennial/ et [Etiology]/ *Rhinitis, Allergic, Perennial/ th [Therapy]/ Skin Tests
Notes: PUBLICATION TYPE: Comparative Study
PUBLICATION TYPE: English Abstract
PUBLICATION TYPE: Journal Article
PUBLICATION TYPE: Randomized Controlled Trial
Abstract: BACKGROUND: More than 10 years ago prick tests have been applied to children from
the age of 12 months and a lot of them were given sublingual immunotherapy with significant
acceptance from family and without undesirable reactions. OBJECTIVE: To assess the efficacy and
safety of sublingual immunotherapy in children. PATIENTS AND METHODS: A clinical trial was
done in 138 children with asthma or rhinitis and positive prick test to Dermatophagoides
pteronyssinus, D. siboney and Blomia tropicalis. Randomly 69 received sublingual immunotherapy,
applying two drops in growing concentrations of 500, 1,000, 2,000, 10,000 and 20,000 biological
units. The concentration of 20,000 was left as maintenance till completes the scheme. RESULTS:
Out of the 138 children included in the study 69, who received sublingual immunotherapy, showed a
difference in variables in relation to control group, and the attendance to emergency services was
lower in the study group than in the control one for a relative risk of 0.39 with a 95% confidence
interval of 0.19, 0.81. Corticosteroid consumption was lower in patients treated for a relative risk of
0.37 and 95% confidence interval of 0.14, 0.79. Out of the 69 patients, 11 had mild (8.6%) and
moderate (7.2%) adverse reactions. CONCLUSIONS: 84% did not have any reaction, thus,
sublingual immunotherapy with allergenic extracts of acarus is effective and safe in the treatment of
asthma and allergic rhinitis.
44. Schubert R, Eickmeier O, Garn H, Baer PC, Mueller T, Schulze J, Rose MA, Rosewich M, Renz H, Zielen S
(Paediatric Pulmonology and Allergology, Department of Internal Medicine III, J.W. Goethe
University, Frankfurt am Main, Germany. [email protected]). Safety and immunogenicity of a
cluster specific immunotherapy in children with bronchial asthma and mite allergy. International
Archives of Allergy & Immunology 2009; 148(3):251-60.
Keywords: AIRWAYS ID: AST/ Adolescent/ Antigens, CD/ me [Metabolism]/ Antigens,
Dermatophagoides/ ad [Administration & Dosage]/ *Antigens, Dermatophagoides/ im
[Immunology]/ Antigens, Dermatophagoides/ tu [Therapeutic Use]/ Asthma/ bl [Blood]/ Asthma/ im
[Immunology]/ *Asthma/ th [Therapy]/ Basophils/ im [Immunology]/ Basophils/ me [Metabolism]/
Breath Tests/ Child/ Desensitization, Immunologic/ ae [Adverse Effects]/ *Desensitization,
Immunologic/ mt [Methods]/ Enzyme-Linked Immunosorbent Assay/ Eosinophil Cationic Protein/
bl [Blood]/ Female/ Forkhead Transcription Factors/ ge [Genetics]/ GATA3 Transcription Factor/ ge
[Genetics]/ Gene Expression/ Humans/ Hypersensitivity/ bl [Blood]/ Hypersensitivity/ im
[Immunology]/ *Hypersensitivity/ th [Therapy]/ Immunoglobulin E/ bl [Blood]/ Immunoglobulin E/
im [Immunology]/ Immunoglobulin G/ bl [Blood]/ Immunoglobulin G/ im [Immunology]/
Leukotrienes/ me [Metabolism]/ Male/ Nitric Oxide/ me [Metabolism]/ Platelet Membrane
Glycoproteins/ me [Metabolism]/ Reverse Transcriptase Polymerase Chain Reaction/ T-Box Domain
Proteins/ ge [Genetics]/ T-Lymphocytes/ me [Metabolism]
Notes: PUBLICATION TYPE: Journal Article
PUBLICATION TYPE: Randomized Controlled Trial
Abstract: BACKGROUND: Cluster specific immunotherapy (SIT) is a modern form of allergen
immunotherapy allowing safe administration of high allergen doses in a short time interval
compared to classic SIT. In the current study, we investigated the safety profile and immunological
effect of cluster SIT in children with allergic asthma due to house dust mite allergy. METHODS: A
total of 34 children (6-18 years) with allergic asthma were assigned to cluster (n = 22) or classic SIT
(n = 12). To achieve a maintenance dose of allergen extract, cluster patients received 14 injections of
house dust mite allergen within 6 weeks, whereas the classic SIT group received 14 injections within
14 weeks. Safety was monitored by recording adverse events. Immunogenicity was measured by
specific IgG(Mite) and IgG4(Mite), by antibody-blocking properties on basophil activation, and by
the T cell subset transcription factors Foxp3, T-bet, and GATA-3. RESULTS: There were no
significant differences in local and systemic side effects between the two groups. In the cluster
group, serum levels of specific IgG(Mite) (p < 0.001) and specific IgG4(Mite) (p < 0.001)
significantly increased after 8 weeks, while it took 12 weeks in the classic SIT group. These data
were confirmed by blocking CD63 expression as well as release of cysteinyl leukotrienes after in
vitro basophil stimulation. No differences in transcription factor expression were found in the two
groups. CONCLUSION: Cluster SIT is safe in children. Additionally, our data demonstrated an even
more rapid induction of specific immune tolerance. Cluster SIT is an attractive alternative to
conventional up-dosing schedules with fewer consultations for the patients. (c) 2008 S. Karger AG,
Basel.
45. Shaheen M, El Ganzory M, Farag F, El Deep E. Bacille Calmette-Guerin vaccine as immunotherapy for
asthmatic children [Abstract]. European Respiratory Society Annual Congress, Berlin, Germany,
October 4-8 2008;[E3056].
Keywords: AIRWAYS ID: AST/ asthma; BCG
46. Stelmach I, Kaczmarek-Wozniak J, Majak P, Olszowiec-Chlebna M, Jerzynska J (Department of Pediatrics
and Allergy, N Copernicus Hospital, 62 Pabianicka Street, Lodz, Poland. [email protected]).
Efficacy and safety of high-doses sublingual immunotherapy in ultra-rush scheme in children
allergic to grass pollen. Clinical & Experimental Allergy 2009 Mar; 39(3):401-8.
Keywords: AIRWAYS ID: AST/ Administration, Sublingual/ Adolescent/ Antigens, Plant/ ae
[Adverse Effects]/ Antigens, Plant/ im [Immunology]/ Antigens, Plant/ pd [Pharmacology]/
*Antigens, Plant/ tu [Therapeutic Use]/ Asthma/ im [Immunology]/ Asthma/ pp [Physiopathology]/
*Asthma/ th [Therapy]/ Child/ Desensitization, Immunologic/ ae [Adverse Effects]/
*Desensitization, Immunologic/ mt [Methods]/ Double-Blind Method/ Female/ Forced Expiratory
Flow Rates/ de [Drug Effects]/ Forced Expiratory Flow Rates/ ph [Physiology]/ Forced Expiratory
Volume/ de [Drug Effects]/ Forced Expiratory Volume/ ph [Physiology]/ Humans/ Immunoglobulin
E/ bl [Blood]/ Immunoglobulin E/ im [Immunology]/ Immunoglobulin G/ bl [Blood]/ Male/ Peak
Expiratory Flow Rate/ de [Drug Effects]/ Peak Expiratory Flow Rate/ ph [Physiology]/ *Poaceae/ im
[Immunology]/ *Pollen/ im [Immunology]/ Treatment Outcome
Notes: PUBLICATION TYPE: Journal Article
PUBLICATION TYPE: Randomized Controlled Trial
Abstract: BACKGROUND: Although sublingual immunotherapy (SLIT) has been used with
increasing frequency, the data on the efficacy of SLIT in pediatric asthma are limited. AIM: The aim
of our study was to evaluate the efficacy and the safety of high-dose SLIT given pre-seasonally and
co-seasonally in an ultra-rush scheme in children with bronchial asthma allergic to grass pollen.
METHODS: Fifty children with asthma, aged 6-17, sensitive to grass pollen, participated in the
2-year prospective, randomized, double-blind, placebo-controlled trial, to investigate the efficacy
and safety of SLIT (Staloral 300 IR, Stallergenes SA, 25 microg major allergens) as a standardized
extract of five grass pollen with ultra-rush induction. RESULTS: SLIT significantly improved
asthma symptom scores (41% vs. placebo group), reduced nasal symptoms (25% vs. placebo group)
and the use of rescue medications (10% vs. placebo group), improved forced expiratory volume in 1
s, but had no effect on ocular symptoms, nasal hyper-reactivity, peak expiratory flow and forced
expiratory volume between 25% and 75% of vital capacity. Serum levels of immunoglobulin E and
IgG4 did not change after SLIT. After the second season of SLIT, an improvement in bronchial
hyperresponsiveness was observed; however, compared with placebo, this effect was not significant.
Among all subjects in SLIT group, predominantly local reactions have been recorded in 59% of
subjects in the first year of treatment and in 35% in the second. CONCLUSIONS: Our study
indicated that high-dose ultra-rush, co-seasonal SLIT given for 2 years, was safe and reduced a
multiple symptom-medication score.
47. Tsai T-C, Lu J-H, Chen S-J, Tang R-B (R.-B. Tang, Department of Pediatrics, Taipei Veterans General
Hospital, School of Medicine, Taipei, Taiwan (Republic of China). E-mail: [email protected]).
Clinical Efficacy of House Dust Mite-specific Immunotherapy in Asthmatic Children. 2010110440,
English. Pediatrics and Neonatology 2010;51(1):14-8.
Keywords: AIRWAYS ID: AST/ *Allergic Asthma/ Dt [Drug Therapy]; Article; Child; Child
Hospitalization; Clinical Article; Clinical Trial; Controlled Clinical Trial; Controlled Study;
*Dermatophagoides Farinae; *Dermatophagoides Pteronyssinus; Disease Severity; Drug Dose
Increase; Drug Dose Regimen; Drug Efficacy; Drug Megadose; Drug Use; Female; Forced
Expiratory Volume; Health Service; Human; *Immunotherapy; Injection Site Swelling/ Si [Side
Effect]; Low Drug Dose; Maintenance Therapy; Male; Medical Care; Randomized Controlled Trial;
Scoring System; Symptom; Beta 2 Adrenergic Receptor Stimulating Agent/ Cb [Drug Combination];
Beta 2 Adrenergic Receptor Stimulating Agent/ Dt [Drug Therapy]; Beta 2 Adrenergic Receptor
Stimulating Agent/ Ih [Inhalational Drug; Administration]; Corticosteroid/ Cb [Drug Combination];
Corticosteroid/ Do [Drug Dose]; Corticosteroid/ Dt [Drug Therapy]; Corticosteroid/ Ih [Inhalational
Drug Administration]; *House Dust Allergen/ Ae [Adverse Drug Reaction]; *House Dust Allergen/
Ct [Clinical Trial]; *House Dust Allergen / Do [Drug Dose]; *House Dust Allergen/ Dt [Drug
Therapy]; *House Dust Allergen/ Sc [Subcutaneous Drug Administration]; Leukotriene Receptor
Affecting Agent/ Dt [Drug Therapy]; Prednisolone/ Dt [Drug Therapy]; Prednisolone/ Po [Oral Drug
Administration]; Theophylline/ Cb [Drug Combination]; Theophylline/ Dt [Drug Therapy]
Notes: Publication Type: Journal: Article
Abstract: Background: Immunotherapy has been widely used in the treatment of allergic diseases.
We evaluated the clinical efficacy of specific immunotherapy with extracts of Dermatophagoides
pteronyssinus (Dp) and Dermatophagoides farinae (Df) in children with asthma. Methods: All 40
children had moderate-to-severe asthma and positive allergen tests for Dp and Df. All required daily
medication. They were randomly assigned to two groups: Half of them received immunotherapy
with subcutaneous injections of Dp and Df extracts, while the other half were not given
immunotherapy. Participants were followed up for more than 6 months. Results: Children in both
groups had apparent improvements in medication use and symptoms after 6 months. The mean
medication scores declined from 3.6 +/- 1.14 to 1.7 +/- 0.66 in the immunotherapy group (p < 0.01)
and from 3.35 +/- 0.87 to 2.4 +/- 1.09 in the control group (p < 0.01). There was a significant
difference between the two groups (mean difference 0.95; p < 0.01). The symptom score improved
in the immunotherapy group from 2.65 +/- 0.98 to 1.20 +/- 1.00 (p < 0.01) and in the control group
from 2.55 +/- 0.99 to 1.40 +/- 0.88 (p < 0.01), with a significant difference between the two groups
(mean difference 0.3; p < 0.01). The number of office visits in the immunotherapy group was greater
than that of the controls, but the frequencies of emergency room visits and hospitalization decreased.
Conclusion: Our study showed that specific immunotherapy with Dp and Df was beneficial for
asthmatic children. copyright 2010 Taiwan Pediatric Association
48. Voltolini S, Troise C, Incorvaia C, Bignardi D, Di Cara G, Marcucci F, La Grutta S, Frati F (S. Voltolini, S.
Voltolini S. Voltolini Department of Internal Medicine, Allergy Unit, San Martino Hospital, Genoa,
Italy). Effectiveness of high dose sublingual immunotherapy to induce a stepdown of seasonal
asthma: a pilot study. 0019895362, English. Current Medical Research and Opinion
2010;26(1):37-40.
Keywords: AIRWAYS ID: AST/ Adult; Article; *Asthma/ Th [Therapy]; Drug Administration
Route; Female; Human; *Immunotherapy; Male; Middle Aged; Pilot Study; Season; Placebo
Notes: Publication Type: Journal: Article
Abstract: BACKGROUND: There is ample evidence to support the efficacy of sublingual
immunotherapy (SLIT) on allergic rhinitis, while there is less solid data regarding asthma. We
evaluated the effects of a high dose birch SLIT on birch-induced rhinitis and asthma in a controlled
study. METHODS: This double-blind, placebo-controlled, randomised, single centre trial on SLIT
with birch pollen allergen extract (Stallergenes, Antony, France) included 24 patients presenting
severe rhinitis and slight to moderate asthma, 14 actively and 10 placebo treated. SLIT was
performed by a pre-coseasonal protocol, and was repeated for 2 years. The study plan included a
selection visit, a visit at the start of the first and the second treatment cycle, a follow-up visit after
1-3 months from the start of each cycle, and a final visit at the end of each yearly cycle. RESULTS:
A significant decrease (p < 0.05) in rhinorrhoea and nasal obstruction occurred in actively treated
patients. The median number of days with asthma at visit 3 was 10 (0-27) in the active (SLIT) group
and 13 (0-29) in the placebo group. The median number of days with asthma at visit 6 was 2 (0-6) in
the SLIT group and 7 (0-15) in the placebo group (p < 0.05 between groups). A stepdown of asthma
occurred in 77% of actively treated vs. none of placebo treated patients (p = 0.05). No severe adverse
events were observed. CONCLUSIONS: This pilot study suggests that SLIT with high dose birch
extract may be able to step down seasonal pollen-induced asthma after prolonged treatment.
Electronic ISSN 1473-4877
49. Wahn U, Bauer C, Agertoft L, Melac M , and Le Gall M. Agreement of efficacy assessments for five grass
pollen sublingual immunotherapy (SLIT) tablets in children and adolescents with grass pollen
rhinoconjunctivitis and with or without mild asthma. CN-00688947. Journal of Allergy & Clinical
Immunology 2009;123(2 Suppl 1):Abstract No. 214.
Keywords: AIRWAYS ID: AST
Abstract: American Academy of Allergy, Asthma and Immunology (AAAAI) 65th Annual Meeting,
March 13-17, 2009, Washington, USA
50. Wahn U, Bauer C, Agertoft L, Mlac M, Le Gall M. Agreement of Efficacy Assessments for Five Grass
Pollen Sublingual Immunotherapy (SLIT) Tablets in Children and Adolescents with Grass Pollen
Rhinoconjunctivitis and with or without Mild Asthma [Abstract]. doi: DOI:
10.1016/j.jaci.2008.12.195. Journal of Allergy and Clinical Immunology 2009;123(2 Suppl 1):S59.
Keywords: AIRWAYS ID: AST/ asthma; rhinoconjunctivitis
Abstract: American Academy of Allergy Asthma & Immunology (AAAAI) Annual Meeting 2009
51. Wurtzen PA, Lund G, Lund K, Arvidsson M , Rak S, Ipsen H. A double-blind placebo-controlled birch
allergy vaccination study II: Correlation between inhibition of IgE binding, histamine release and
facilitated allergen presentation. 2008348028. Clinical and Experimental Allergy 2008;38
(8):1290-301.
Keywords: AIRWAYS ID: AST/ Adaptive Immunity; *Allergic Asthma/ Dt [Drug Therapy];
*Allergic Asthma/ Pc [Prevention]; Antigen Presenting Cell; Article; B Lymphocyte; Basophil;
Birch; Clinical Article; Clinical Trial; Complex Formation; Controlled Clinical Trial; Controlled
Study; Double Blind Procedure; Drug Effect; Flow Cytometry; Histamine Release; Human;
Immunotherapy; *Pollen Allergy/ Dt [Drug Therapy]; *Pollen Allergy/ Pc [Prevention]; Priority
Journal; Protein Binding; Randomized Controlled Trial; *Rhinoconjunctivitis/ Dt [Drug Therapy];
*Rhinoconjunctivitis/ Pc [Prevention]; T Lymphocyte Activation; Vaccination; Allergen; *Alutard/
Ct [Clinical Trial]; *Alutard/ Dt [Drug Therapy]; Blocking Antibody/ Ec [Endogenous Compound];
Cd23 Antigen/ Ec [Endogenous Compound]; Immunoglobulin E/ Ec [Endogenous Compound];
Placebo
Abstract: Background: The pathogenesis of IgE-mediated allergic disease is closely related to the
production of T-helper type 2 (Th2) cytokines, which lead to IgE production pivotal for activation of
mast cells and basophils. Proliferating T cells along with eosinophils expanded and attracted by Th2
cytokines are major contributors to the late-phase reaction. The activation of these Th2 cells is
strongly enhanced by CD23-mediated IgE facilitated allergen presentation (FAP). Objective: The
present study aims to investigate the effect of specific immunotherapy (SIT)-induced
allergen-specific non-IgE antibodies (blocking antibodies) on IgE binding to allergen, histamine
release (HR) and CD23-mediated allergen uptake in antigen-presenting cells. Methods: Competition
between IgE and non-IgE for allergen binding was studied by Advia Centaur antibody
measurements, passively sensitized basophils were used to study HR and IgE-facilitated binding of
allergen to B cells (FAP) was studied by flow cytometry. FAP measurements were performed both
with and without the addition of a reference IgE serum, which was included to obtain optimal
complex formation. The serum samples were obtained from birch pollen immunotherapy (n=21) or
placebo control patients (n=21) before and after 1 and 2 years of treatment. Results: Statistically
significant reduction of all parameters investigated was observed after 1 year of treatment and the
effect was maintained during the second year of treatment. There was a clear correlation between the
two FAP measurements and between each of them and the level of T cell activation reported upon
previously. Moreover, strong correlations were found between changes in FAP, IgE binding and HR.
Conclusion: The present study clearly demonstrates that SIT induces changes in the composition of
serum antibodies that inhibit IgE binding, HR and FAP to a similar extent. This suggests that these
measurements, individually or in combination, may be used to monitor the immunological effect of
SIT, even though direct correlations to changes in clinical parameters could not be demonstrated.
copyright 2008 The Authors. Drug Trade Names and Manufacturers Alk Abello [Denmark] alutard:
Alk Abello [Denmark]
52. Zhou RL. Clinical observation on the effect of acupoint desensitization for allergic asthma. CN-00736343.
Journal of Integrated Traditional and Western Medicine[Zhong Xi Yi Jie He Za Zhi]
1989;9(4):216-7.
Keywords: AIRWAYS ID: AST/ asthma
Notes: HS from the Cochrane Complementary Medicine Field