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TM TM Prepared for your next patient. Pediatric Asthma Evaluation & Management Bradley E. Chipps, MD, FAAP Capital Allergy & Respiratory Disease Center Sacramento, CA TM Disclaimers Statements and opinions expressed are those of the authors and not necessarily those of the American Academy of Pediatrics. Mead Johnson sponsors programs such as this to give healthcare professionals access to scientific and educational information provided by experts. The presenter has complete and independent control over the planning and content of the presentation, and is not receiving any compensation from Mead Johnson for this presentation. The presenter’s comments and opinions are not necessarily those of Mead Johnson. In the event that the presentation contains statements about uses of drugs that are not within the drugs' approved indications, Mead Johnson does not promote the use of any drug for indications outside the FDA-approved product label. TM Definition of Asthma A chronic inflammatory disease of the airways with the following clinical features: Episodic and/or chronic symptoms of airway obstruction Bronchial hyperresponsiveness to triggers Evidence of at least partial reversibility of the airway obstruction Alternative diagnoses are excluded TM Diagnosis 1. History 2. Pulmonary function tests (PFTs) 3. Challenge studies TM Wheezing—Asthma? Wheezing with upper respiratory infections is very common in small children, but: Many of these children will not develop asthma. Asthma medications may benefit patients who wheeze whether or not they have asthma. All that wheezes is not asthma. TM Cough—Asthma? Consider asthma in children with: Recurrent episodes of cough with or without wheezing Nocturnal awakening because of cough Cough that is associated with exercise/play Cough without wheeze is often not asthma Cough may be the only symptom present in patients with asthma. Goldsobel AB, Chipps BE. Cough in the pediatric population. J Pediatr. 2010;156(3):352–358 TM Asthma Predictive Index Identify high risk children (2 and 3 years of age): • ≥4 wheezing episodes in the past year (at least one must be MD diagnosed) PLUS One major criterion • Parent with asthma • Atopic dermatitis • Aero-allergen sensitivity OR Two minor criteria • Food sensitivity • Peripheral eosinophilia (≥4%) • Wheezing not related to infection Modified from: Castro-Rodriguez JA, Holberg CJ, Wright AL, et al. A clinical index to define risk of asthma in young children with recurrent wheezing. Am J Respir Crit Care Med. 2000;162(4 Pt 1):1403–1406 TM Objective Evaluation of Asthma Physical examination Pulmonary function Bronchoprovocation Validated control tools TM Defining Asthma Severity and Control 1) 0–4 years 2) 5–11 years 3) 12 years and older TM How Can Asthma Control Be Measured? Inflammation? Direct or indirect? Lung function? Daytime symptoms? Utilization of healthcare resources? Functional status? Nighttime awakenings? Asthma Control Missed work and/or school? Patient self-report of control? Asthma control test is a trademark of QualityMetric Incorporated. Use of “quick relief” inhaler and/or nebulizer? TM 35 Asthma Control Cannot be Assessed at a Single Time Point % of Patients 30 25 20 15 10 5 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15-19 20-24 25+ Number of Changes Over Weeks 1–12 Approximately one-third of both adult and pediatric subjects had 15 or more changes in their asthma severity classification based upon peak expiratory flow (PEF) during the 12-week studies. Chipps BE, Span JD, Sorkness CA, et al. Variability in asthma severity in pediatric subjects with asthma previously receiving short-acting beta2agonists. J Pediatr. 2006;148(4):517–521; Calhoun WJ, Sutton LB, Emmett A, et al. Asthma variability in patients previously treated with beta2agonists alone. J Allergy Clin Immunol. 2003;112(6):1088–1094 TM Classifying Asthma Severity and Initiating Treatment in Children 0 to 4 Years of Age Adapted from: National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma. US Department of Health and Human Services. Available at: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf. Accessed July 5, 2012 TM Assessing Asthma Control and Adjusting Therapy in Children 0 to 4 Years of Age Adapted from: National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma. US Department of Health and Human Services. Available at: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf. Accessed July 5, 2012 Test for Respiratory and Asthma Control in Kids (TRACK) TM TM Stepwise Approach for Managing Asthma in Children 0 to 4 Years of Age Adapted from: National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma. US Department of Health and Human Services. Available at: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf. Accessed July 5, 2012 TM Classifying Asthma Severity and Initiating Treatment in Children 5 to 11 Years of Age TM Assessing Asthma Control and Adjusting Therapy in Children 5 to 11 Years of Age TM Childhood Asthma Control Test™ TM Stepwise Approach for Managing Asthma in Children 5 to 11 Years of Age Adapted from: National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma. US Department of Health and Human Services. Available at: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf. Accessed July 5, 2012 TM Classifying Asthma Severity and Initiating Treatment in Youth ≥12 Years of Age and Adults TM Assessing Asthma Control in Children ≥12 Years of Age and Adults TM Asthma Control Test™ (ACT) TM Stepwise Approach for Managing Asthma in Children 12 Years of Age and Adults TM Infants and Young Children— When to Start Controllers >3 episodes of wheezing in the last year, and Parental history of asthma or physician diagnosis of eczema Or 2 of the following: Physician diagnosis of allergic rhinitis, wheezing apart from colds, peripheral eosinophilia Courses of oral steroids more often than every 6 weeks Symptoms >2 times per week, nocturnal symptoms >2 times per month TM Step-down Therapy Step down once control is achieved: After 2–3 months 25% reduction over 2–3 months Follow-up monitoring: Every 1–6 months Assess symptoms. Review medication use. Objective monitoring (PEF or spirometry) Review medication. TM Step-up Therapy Indications: Symptoms, need for quick-relief medication, exercise intolerance, decreased lung function • May need a short course of oral steroids. Continue to monitor. • Follow and reassess every 1–6 months • Step down when appropriate. TM Phenotypic Expressions of Childhood Wheezing Disorders 1. Viral induced wheezing 2. Severe intermittent wheezing 3. Exercise bronchospasm/asthma 4. Persistent asthma 5. Severe asthma TM Viral Induced Wheezing 1. Triggered by viral infections 2. Non-atopic 3. Remission in childhood TM Infants TM Intermittent Inhaled Corticosteroids (ICS) in Infants with Episodic Wheezing Single randomized double-blind study N=411 infants with a 3-day history of wheezing Infants treated with budesonide 400 µg/d or placebo for 2 weeks Primary outcome variables were: • • • • Number of symptom free days Number of days free from rescue medication use Number of episodes Number of treatments with open label budesonide Bigaard H, Hermansen MN, Loland L, et al. Intermittent inhaled corticosteroids in infants with episodic wheezing. N Eng J Med. 2006;354(19):1998–2005 Intermittent ICS in Infants: Withdrawal Due to Persistent Wheezing TM Percentage of Children Withdrawn Because of Persistent Wheezing 50 40 30 Budesonide 20 Placebo 10 P=0.41 0 0 100 200 300 400 500 600 700 800 900 Days after Randomization No. at Risk Budesonide 149 115 78 27 Placebo 145 114 92 27 Progression from episodic to persistent wheezing. Results were not significant. Bigaard H, Hermansen MN, Loland L, et al. Intermittent inhaled corticosteroids in infants with episodic wheezing. N Eng J Med. 2006;354(19):1998– 2005 TM Role of Viral Infections TM Rhinovirus (RV) Wheezing versus Respiratory Syncytial Virus (RSV) Wheezing in First 3 Years of Life and Asthma at 6 Years of Age Jackson DJ, Gangnon RE, Evans MD, et al. Wheezing rhinovirus illnesses in early life predict asthma development in high-risk children. Am J Respir Crit Care Med. 2008; 178(7):667–672 TM Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted TM RV Infections and the Development of Asthma RV infections can produce more than upper airway illnesses during infancy. Children who develop asthma by 6 years of age have a significantly increased burden of viral wheezing illnesses in early life. Pulmonary function abnormalities at 6 years of age are most significantly associated with early childhood wheezing illnesses due to RV (not RSV). Of all outpatient wheezing viral illnesses in early life, those due to RV are most significant. TM Oral Prednisolone for Preschool Children with Acute Virus-induced Wheezing Randomized, double-blind, placebo-controlled trial comparing a 5-day course of oral prednisolone (10 mg daily for children 10–24 months and 20 mg daily for older children) versus placebo in 700 children between the ages of 10 and 60 months. No difference in 7-day symptom scores, albuterol use, or readmission Primarily non-atopic and 60% first time wheezers Panickar J, Lakhanpaul M, Lambert PC, et al. Oral prednisolone for preschool children with acute virus-induced wheezing. N Engl J Med. 2009;360(4):329–338 TM Severe Intermittent Wheezing TM Acute Intermittent Management Strategies (AIMS)—Primary Hypothesis In young children with recurrent severe wheezing, intervention with an ICS or leukotriene receptor antagonist (LTRA) at the onset of respiratory tract illness (RTI)-associated symptoms will increase the proportion of episode-free days over a 12-month period compared with conventional therapy.* *Conventional therapy—inhaled bronchodilator followed by the sequential addition of systemic corticosteroids Episodic Use of an ICS or LTRA in Preschool Children with Moderate-to-Severe Intermittent Wheezing TM Acute Intermittent Management Strategies (AIMS) Study Overview At first sign of RTI symptoms x 7 days Budesonide 1 mg bid + Placebo LTRA + b-agonist Run in Randomization Montelukast 4 mg daily + Placebo ICS + b-agonist Placebo LTRA + Placebo ICS + b-agonist Randomized, multicenter, double-blind, placebo-controlled 1 year trial 238 children, 12–59 months, with recurrent episodes of intermittent wheezing • 2 episodes in the previous year • 2 urgent care visits, 2 oral steroid courses, or 1 of each Primary outcome = episode free days Secondary outcomes = symptoms scores during illnesses and oral corticosteroids (OCS) use Bacharier LB, Phillips BR, Zeiger RS, et al. Episodic use of an inhaled corticosteroid or leukotriene receptor antagonist in preschool children with moderate-to-severe intermittent wheezing. J Allergy Clin Immunol. 2008;122(6):1127–1135 TM 1° Outcome—Mean Proportion of Episode Free Days Proportion of episode free days adjusted for age group, API status, center TM Maintenance versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST) Study 1. 12 month R, DB, active control: 278 children (12–53 months) 2. 4 episodes of wheezing last year: Positive mAPI 1 episode: OCS, emergency department, urgent care or hospital 3. Primary outcome: Exacerbation with OCS TM Run-in: 2 weeks Treatment Phase: 52 weeks Randomized Pbo run-in nightly + Albuterol PRN Treatment Group Daily low dose budesonide Nightly, except During RTIs during RTI only for 7 days 0.5 mg PM Pbo AM 0.5 mg PM Intermittent high dose budesonide Pbo PM 1.0 mg AM 1.0 mg PM TM MIST Study 1. Exacerbations 0.95/patient year; p=0.6 2. Similar time to first exacerbation; p=0.87 3. No difference in treatment failures or episode free days 4. Height=0.26 cm average difference; weight=0.16 Kg average difference TM Diagnosis of Exercise-induced Bronchospasm (EIB) / Exerciseinduced Asthma (EIA) TM EIA Therapy—General Principles EIA may reflect suboptimally controlled asthma, which may require adjustment of overall therapy of asthma. Goal: Facilitate normal activity levels, including competitive sports. Individualize therapy. Child needs to understand and be a partner in therapy. TM Diagnosis of EIB Normal PFT at rest No other stimulus for bronchospasm Most common in allergic rhinitis patients Dx: 10% decrease FEV1 after 8 minutes of exercise at 90% maximum predicted heart rate Rx: B-agonist before exercise, LTRA daily TM Diagnosis of EIA Normal or obstructive PFT at rest Patient has other stimuli for asthma symptoms. Patient has both inflammatory and bronchospasm component. Dx: Same criteria Rx: ICS, LTRA, ICS/long-acting beta antagonist (LABA) daily, B-agonist before exercise TM Persistent Asthma TM Multicentre Allergy Study (MAS) 1. Birth cohort: 1314 • 13-year follow up: 441 (33.6% all visits) • No wheeze 1st year: 315 (74%) 2. Early wheezers: 126 • No wheeze (4–13 years): 79 (68%) • Initial wheeze: 43 (34%) • Persistent wheeze: 4 (3%) 3. Wheeze 3–6 years: 40 (13%) 4. Wheeze 6–13 years: 42 (13%) Matricardi PM, Illi S, Grüber C, et al. Wheezing in childhood: incidence, longitudinal patterns and factors predicting persistence. Eur Respir J. 2008;32(3):585–392 TM The Prevalence of Wheezing Varies Depending on Age and Atopic Status Prevalence (%) Atopic (n=94) Non-atopic (n=59) 80 70 60 50 40 30 20 10 0 1 2 3 4 5 6 7 8 9 10 11 12 13 Age (years) Illi S, von Mutius E, Lau S, et al. Perennial allergen sensitisation early in life and chronic asthma in children: a birth cohort study. Lancet. 2006;368(9537):763–770 TM Time of Sensitization and Degree of Exposure to Indoor Allergens and Lung Function Impairment at 7 Years of Age 120 115 110 105 100 95 90 85 115 p=0.009 p=0.003 110 105 100 95 90 85 80 80 75 70 0 75 NS S/LE S/HE NS S/LE S/HE FEV1 (% pred) MEF50 (% pred) 70 0 NS S/LE S/HE NS S/LE S/HE FEV1 (% pred) MEF50 (% pred) Illi S, von Mutius E, Lau S, et al. Perennial allergen sensitisation early in life and chronic asthma in children: a birth cohort study. Lancet. 2006;368(9537):763–770 TM Melbourne Epidemiological Study Phelan PD, Robertson CF, Olinsky A. The Melbourne Asthma Study: 1964-1999. J Allergy Clin Immunol. 2002;109(2):189–194 A Longitudinal, Population-based, Cohort Study of Childhood Asthma Followed to Adulthood TM Sears MR, Greene JM, Willan AR, et al. A longitudinal population-based, cohort study of childhood asthma followed to adulthood. N Engl J Med. 2003;349(15):1414–1422 TM ICS Therapy in Preschool Children Multicenter, double-blind, randomized placebo controlled study designed to determine if ICS therapy can modify the subsequent development of asthma in high risk children Children with a positive asthma predictive index (2–3 years of age, N=285) treated with either fluticasone 88 µg BID or placebo for 2 years followed by a year of observation Primary outcome variable: Proportion of episode free days Guilbert TW, Morgan WJ, Zeiger RS, et al. Long-term inhaled corticosteroids in preschool children at high risk for asthma. N Engl J Med. 2006; 354(19):1985–1997 Fluticasone Had No Carryover Effect During the Observation Period TM Proportion of Episode-free Days p=0.78 p=0.006 1.00 0.95 Fluticasone Placebo 0.90 0.85 0.80 0.75 0.00 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 Months Treatment Period Observation Period The increase in symptom free days in the fluticasone cohort during the treatment period was lost in the 12 months subsequent during the observation period. Guilbert TW, Morgan WJ, Zeiger RS, et al. Long-term inhaled corticosteroids in preschool children at high risk for asthma. N Engl J Med. 2006;354(19):1985–1997 TM The Need for Oral Corticosteroids Children Not Receiving Supplementary Medication All Children No Need for a First course of Prednisolone (% of children) Observation Treatment 100 100 Fluticasone 75 Observation 75 50 Placebo 50 Placebo 25 25 0 0 0 6 Fluticasone 12 18 24 30 36 Months 0 24 26 28 30 32 34 36 Months No. at Risk No. at Risk Fluticasone 143 102 80 66 57 42 Fluticasone 132 88 Placebo 142 87 62 57 50 41 Placebo 130 85 TM No Need for Supplementary Asthma-Controller Medication (% of children) The Need for Supplementary Controller Meds: No Difference at 36 months 100 100 Fluticasone Fluticasone 75 75 Placebo Placebo 50 50 25 25 0 0 0 6 12 18 24 30 36 0 Months No. at Risk No. at Risk Fluticasone 143 131 118 116 113 99 Placebo 142 125 103 99 93 86 24 26 28 30 32 34 36 Months Fluticasone 132 111 Placebo 130 105 The fluticasone group had less of a need for supplementary medications during the treatment period (p<0.01). By the end of the observation period (36 months), the groups were indistinguishable (P=0.99) Guilbert TW, Morgan WJ, Zeiger RS, et al. Long-term inhaled corticosteroids in preschool children at high risk for asthma. N Engl J Med. 2006; 354(19):1985–1997 TM 20 15 10 5 0 0 10 20 Months 30 Difference in Height Change between Fluticasone and Placebo Groups (cm) Change in Height from Baseline (cm) Changes in Height from Baseline and Between Groups 0 -0.5 -1.0 -1.5 Month 0 1 4 10 20 30 8 12 16 20 24 28 32 36 P value Change in height from baseline represented by the panel on the left. The difference between groups with associated p-values represented on the right. At the end of 24 months the fluticasone group averaged 1.1 cm less than the placebo group. At the end of the observation period (36 months) the difference between groups was 0.7 cm. Guilbert TW, Morgan WJ, Zeiger RS, et al. Long-term inhaled corticosteroids in preschool children at high risk for asthma. N Engl J Med. 2006; 354(19):1985–1997 TM Summary and Clinical Implications Based on the results of the Prevention of Early Asthma in Kids (PEAK) study: ICS are effective in improving asthma-like symptom burden, exacerbations, and lung function in high risk toddlers. Continuous ICS therapy for 2 years once discontinued does not modify the natural history of asthma in early childhood. TM START INHALED STEROID TREATMENT AS REGULAR THERAPY IN EARLY ASTHMA The World’s Largest Study in Asthma Therapy Pauwels RA, Pedersen S, Busse WW, et al. Early intervention with budesonide in mild persistent asthma: a randomised, double-blind trial. Lancet. 2003;361(9363):1071–1076 TM Primary Study Objective and Primary Variables Examines effect of early intervention with ICS on evolution of newly diagnosed asthma Primary outcome: • Time to first severe asthma-related event (SARE) during first 3 years of study • A severe event requiring hospitalization or emergency treatment due to worsening of asthma or death due to asthma Secondary outcome: • Change in postbronchodilator FEV1 Intent to treat analysis Pauwels RA, Busse WW, O’Byrne PM, et al. The inhaled Steroid Treatment as Regular Therapy in early asthma (START) study: rationale and design. Control Clin Trials. 2001;22(4):405–419 TM Double-blind (Part A) and Open-label (Part B) Design Part A – Pulmicort therapy Adults Pulmicort 400 g once daily + usual asthma therapy Children (6–10 y of age) Part B: Open-label Adults Pulmicort 400 g once daily + usual asthma therapy Pulmicort 200 g once daily + usual asthma therapy Part A – Reference therapy Children (6–10 y of age) Pulmicort 200 g once daily + usual asthma therapy Adults and Children Placebo once daily + usual asthma therapy Year 0 1 2 3 4 5 Visit 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 TM Time to First SARE Cumulative Probability 44% (95% CI, 29–55%) reduced risk of first SARE* 0.10 Budesonide therapy Reference therapy 0.08 0.06 0.04 0.02 0.00 0 1 2 3 *Hazard ratio = 0.56; P<.0001. Pauwels RA, Pedersen S, Busse WW, et al. Early intervention with budesonide in mild persistent asthma: a randomised, double-blind trial. Lancet. 2003;361(9363):1071–1076 TM Patients Requiring Additional Corticosteroids* 60 % of Patients 50 40 30 20 10 0 Budesonide Therapy Reference Therapy *Inhaled, oral, or systemic Pauwels RA, Pedersen S, Busse WW, et al. Early intervention with budesonide in mild persistent asthma: a randomised, double-blind trial. Lancet. 2003;361(9363):1071–1076 TM Changes in Postbronchodilator FEV1 Over 3 Years Pauwels RA, Pedersen S, Busse WW, et al. Early intervention with budesonide in mild persistent asthma: a randomised, double-blind trial. Lancet. 2003;361(9363):1071–1076 TM Early Intervention with Budesonide in Mild Persistent Asthma Sullivan SD. Early intervention with budesonide in mild persistent asthma—the START study. Presented at the European Respiratory Society (ERS). Stockholm, Sweden, 2002 TM Early Intervention with Budesonide in Mild Persistent Asthma Budesonide therapy reduces the risk of a severe asthma exacerbation by 44% in patients with mild persistent asthma. Daily treatment with low dose budesonide decreases the need for oral corticosteroids in mild persistent asthma. Budesonide daily improves asthma control • More symptom free days • Less additional asthma medication Pauwels RA, Pedersen S, Busse WW, et al. Early intervention with budesonide in mild persistent asthma: a randomised, double-blind trial. Lancet. 2003;361(9363):1071–1076 TM BADGER Trial TM BADGER Trial 1. 182 children (6–17 years of age), uncontrolled asthma, FP 100 µg BID, triple crossover design, 16-week period 2. FP 250 µg BID FP 100 µg + SALM 50 µg BID FP 100 µg BID + MTL 5 or 10 mg daily 3. 3 outcomes • Exacerbations • Symptom free days • FEV1 (Pre) Lemanske RF, Mauger DT, Sorkness CA, et al. Step-up therapy for children with uncontrolled asthma receiving inhaled corticosteroids. N Engl J Med. 2010;362:975–985 TM Primary Predictors of a Differential Response to Step-up Therapy Lemanske RF, Mauger DT, Sorkness CA, et al. Step-up therapy for children with uncontrolled asthma receiving inhaled corticosteroids. N Engl J Med. 2010;362:975–985 TM Primary Predictors of a Differential Response to Step-up Therapy Lemanske RF, Mauger DT, Sorkness CA, et al. Step-up therapy for children with uncontrolled asthma receiving inhaled corticosteroids. N Engl J Med. 2010;362:975–985 TM Secondary Predictors of a Differential Response to Step-up Therapy Lemanske RF, Mauger DT, Sorkness CA, et al. Step-up therapy for children with uncontrolled asthma receiving inhaled corticosteroids. N Engl J Med. 2010;362:975–985 TM Enrollment, Outcomes, and Schedule of Evaluations Lemanske RF, Mauger DT, Sorkness CA, et al. Step-up therapy for children with uncontrolled asthma receiving inhaled corticosteroids. N Engl J Med. 2010;362:975–985 TM Pairwise Comparisons Lemanske RF, Mauger DT, Sorkness CA, et al. Step-up therapy for children with uncontrolled asthma receiving inhaled corticosteroids. N Engl J Med. 2010;362:975–985 TM Probability of Best Response Lemanske RF, Mauger DT, Sorkness CA, et al. Step-up therapy for children with uncontrolled asthma receiving inhaled corticosteroids. N Engl J Med. 2010;362:975–985 TM Severe Asthma TM Severe Asthma Refractory Difficult to control asthma Uncontrolled asthma refractory to conventional treatment Frequent exacerbations ? Distinct phenotype or subgroup TM Reasons for Failure to Achieve Control Compliance Asthma heterogeneity Wrong diagnosis Wrong target Failure to deliver drug to the target site TM Demographic and clinical characteristics of children and adolescents with severe or difficult-to-treat asthma TM TENOR Study Design 3-year, multi-center, observational study • Patients continued to receive medications and treatments administered for their asthma as indicated by their physician. 4,756 patients enrolled between January and October 2001 • 6 years of age or older • 283 sites across the US Dolan CM, Fraher KE, Bleecker ER, et al. Design and baseline characteristics of The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study: a large cohort of patients with severe or difficult-to-treat asthma. Ann Allergy Asthma Immunol. 2004; 92(1):32–39 TM Objectives Primary objective • Describe the natural history of patients considered by physicians to have “severe” or “difficult-to-treat” asthma. Secondary objectives • Examine relationship between features of asthma, treatments, and outcomes. • Observe frequency of comorbid conditions. • Examine the relationship between immunoglobulin and disease. TM Methods Cross-sectional baseline data analyzed TENOR patients between 6 and 17 years of age included (N=1,261) Patients categorized into 4 age groups by gender: Age group (years) 6-8 9-11 12-14 15-17 Males (N=791) n (%) 145 (18) 282 (36) 240 (30) 124 (16) Females (N=470) n (%) 88 (19) 120 (26) 171 (36) 91 (19) Total (N=1,261) n (%) 233 (18) 402 (32) 411 (33) 215 (17) Chipps BE, Szefler SJ, Simons FE, et al. Demographic and clinical characteristics of children and adolescents with severe or difficult-to-treat asthma. J Allergy Clin Immunol. 2007;119(5):1156–1163 TM Spirometry by Age and Gender Chipps BE, Szefler SJ, Simons FE, et al. Demographic and clinical characteristics of children and adolescents with severe or difficult-to-treat asthma. J Allergy Clin Immunol. 2007;119(5):1156–1163 TM Medication Use by Age *Based on test for linear trend, a statistically significant age trend (P <.05) was seen for methylxanthines and long-acting b-agonists. Chipps BE, Szefler SJ, Simons FE, et al. Demographic and clinical characteristics of children and adolescents with severe or difficult-to-treat asthma. J Allergy Clin Immunol. 2007;119(5):1156–1163 TM Healthcare Utilization by Long-term Controller Use: 6–11 and 12–17 Years of Age Chipps BE, Szefler SJ, Simons FE, et al. Demographic and clinical characteristics of children and adolescents with severe or difficult-to-treat asthma. J Allergy Clin Immunol. 2007;119(5):1156–1163 TM Summary―Predicting Persistence of Wheezing 1. Family history of asthma 2. Recurrent lower airway symptoms in infancy 3. Absence of nasal symptoms at 1 year 4. Atopic sensitization before 4 years and early exposure 5. Eczema 6. Exposure to ETS 7. Females 8. Acetaminophen ? 9. Vitamin D ? TM Thank You TM For more information… On this topic and a host of other topics, visit www.pediatriccareonline.org. Pediatric Care Online is a convenient electronic resource for immediate expert help with virtually every pediatric clinical information need. Musthave resources are included in a comprehensive reference library and time-saving clinical tools. • Haven't activated your Pediatric Care Online trial subscription yet? It's quick and easy: simply follow the steps on the back of the card you received from your Mead Johnson representative. • Haven't received your free trial card? Contact your Mead Johnson representative or call 888/363-2362 today.