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9/16/2014
Chronic Asthma Management
Jessica E. Freshour, PharmD, BCPS
Assistant Professor of Pharmacy Practice
Gatton College of Pharmacy
September 19, 2014
Presentation Objectives
• Evaluate the domains of asthma assessment
• Implement the general principles of chronic asthma management
• Determine the need to adjust therapy based on patient specific information
Asthma Treatment Resources
• Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma: National Heart, Lung and Blood Institute 2007. – Available from: www.nhlbi.nih.gov
• Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2014. – Available from: http://www.ginasthma.org
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Asthma Assessment
• Assessment and monitoring are closely linked to:
– Severity: intrinsic intensity of the disease – Control: degree to which the manifestations of asthma are minimized and goals of therapy are met
– Responsiveness: ease with which asthma control is achieved by therapy
• Severity and control are defined in 2 domains:
– Impairment: frequency and intensity of symptoms and functional limitations the patient is experiencing or has recently experienced
– Risk: likelihood of either asthma exacerbations, progressive decline in lung function or risk of adverse effects from medications
From EPR‐3 Guidelines
Asthma Assessment
• Symptom Control Questions (prior 4 weeks)
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Daytime asthma symptoms > 2 x week?
Any night time awakening due to asthma?
Rescue therapy needed for symptoms > 2 x week?
Any activity limitations due to asthma?
• Level of Asthma Control
– None of the above = well controlled
– 1‐2 of the above = partly controlled
– > 2 of the above = uncontrolled
From GINA Guidelines
Long‐term Asthma Goals
• Achieve good control of symptoms
• Maintain normal activity
• Minimize future risk of exacerbations
• Prevent/minimize fixed airflow limitation
• Minimize drug side effects
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Asthma Medication Categories
• Controller
– Regular maintenance treatment
– Most common – Inhaled Corticosteroids (ICS)
– Others – Leukotriene receptor antagonists (LTRA)
• Reliever (Rescue)
– Short‐acting beta‐agonists (SABA)
– Formoterol (LABA) has an onset similar to SABA
– Other therapies not recommended for routine use (anticholinergics, oral beta‐agonists, theophylline)
• Add‐on therapies
– Anti‐IgE monoclonal antibody (more to come)
– LABA with ICS
Classifying Asthma Severity Without Long‐term Controller– EPR3
Classification of Asthma Severity
Components of Severity
Mild
Moderate
Severe
Symptoms
≤ 2 d/wk
> 2 d/wk, not daily
Daily
Throughout the day
Nighttime awakenings
≤ 2 x/month
3 – 4 x/month
> 1x/wk, not nightly
Often 7x/wk
≤ 2 d/wk
> 2 d/wk, not > 1 x/d
Daily
Several times/day
None
Minor limitations
Some limitations
Extremely limited
FEV1 > 80%
predicted
FEV1 > 60% but < 80% predicted
FEV1 < 60%
predicted
FEV1/FVC normal
FEV1/FVC
reduced 5%
FEV1/FVC reduced more than 5%
SABA for rescue
Impairment
Persistent
Intermittent
Normal activity limits
Normal FEV1
between exacerbations
Lung Function
FEV1 > 80%
predicted
Risk
FEV1/FVC
normal
Exacerbations requiring oral steroids
0 – 1/year
≥ 2/year
Consider severity and interval since last exacerbation
Initial Controller Treatment – GINA Presenting Symptoms (without controller medications)
Preferred initial controller
Symptoms or need for SABA < 2 x month
No nighttime awakening in prior month
No risk factors for exacerbations
No exacerbations in previous year
No controller (Evidence D)
Symptoms same as above but ≥ 1 risk factor for exacerbations Low dose ICS (Evidence D)
Symptoms or need for SABA ≤ 2 x week but > 2 x month
Nighttime awakening ≥ 1 x month
Low dose ICS (Evidence B)
Symptoms or need for SABA > 2 x week
Low dose ICS (Evidence A)
LTRA less effective
Troublesome symptoms most days
Nighttime awakening ≥ 1 x week
Risk factors for exacerbations
Medium/high dose ICS (Evidence A) – or –
Low‐dose ICS/LABA (Evid. A)
Very severe at presentation or presents with an acute exacerbation
Short course of oral steroids and high dose ICS (Evidence
A) or medium dose ICS/LABA (Evidence D)
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Independent risk factors for exacerbations
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Excessive SABA use ( > 1 inhaler/month)
Poor adherence/inhaler technique
Inadequate dose of ICS or no ICS
Low FEV1 (increased risk with FEV1 < 60%)
Psychological or socioeconomic issues
Exposures (smoking, allergens, occupational)
Sputum or blood eosinophilia
Comorbidities (obesity, rhinosinusitis, food allergies, uncontrolled GERD, pregnancy)
• ICU admission or intubation in past for asthma
• ≥ 1 severe exacerbation in the past 12 months
The control-based asthma management cycle
NEW!
GINA 2014, Box 3‐2
© Global Initiative for Asthma
Stepwise management - pharmacotherapy
*For children 6‐11 years, theophylline is not recommended, and preferred Step 3 is medium dose ICS
**For patients prescribed BDP/formoterol or BUD/ formoterol maintenance and reliever therapy
GINA 2014, Box 3‐5 (upper part)
© Global Initiative for Asthma
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Step‐wise Approach
• Step 1
– What is it?
• Short‐acting beta agonists (SABA) as needed for symptoms
• Also encourage prior to exercise (5‐15 minutes before)
– Who is it?
• Infrequent symptoms (< 2 x month) of short duration
• No night time symptoms
• No risk factors for exacerbations
– What to remember?
• This is historical – insufficient evidence for treating asthma with beta‐agonists alone
• Can consider low‐dose ICS if there are risk factors for exacerbations (with SABA for rescue therapy)
• These patients still need frequent assessment – regardless of age
Step‐wise Approach
• Step 2
– What is it?
• Low‐dose ICS for controller therapy
• Short‐acting beta agonists (SABA) as needed for symptoms
• Also encourage prior to exercise (5‐15 minutes before)
– Who is it?
• Symptoms > 2 x month
• Night time symptoms once or more per month
• Risk factor(s) for exacerbations
– What to remember?
• LTRA efficacy < low‐dose ICS – but might work well for select patients
• Seasonal asthma – start ICS when symptoms start and continue for 4 weeks after the relevant pollen season ends
• Low‐dose ICS/LABA combos reduces symptoms and improves lung function compared to ICS alone, but does not further reduce risk of exacerbations • Leave theophylline and nedocromil alone – they belong in a museum
Clinical Comparability in ICS
Adults and adolescents (>12 years old)
Drug
Low
Medium
High
Beclometasone (HFA)
100‐200
>200‐400
>400
Budesonide (DPI)
200‐400
>400‐800 >800
Ciclesonide (HFA)
80‐160
>160‐320
>320
Fluticasone (DPI & HFA)
100‐250
>250‐500
>500
Mometasone
110‐220
>220‐440
>440
Triamcinolone
400‐1000
>1000‐2000
>2000
Children 6‐11 years old
Drug
Low
Medium
High
Beclometasone (HFA)
50‐100
>100‐200
>200
Budesonide (DPI)
100‐200
>200‐400
>400
Ciclesonide (HFA)
80
>80‐160
>160
100‐200 (100‐200)
>200‐400 (>200‐500)
>400 (>500)
Mometasone
100
>110 ‐ <440
≥ 440
Triamcinolone
400‐800
>800‐1200
>1200
Fluticasone (DPI) (HFA)
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Step‐wise Approach
• Step 3
– What is it?
• Combo low‐dose ICS/LABA for controller therapy
• Short‐acting beta agonists (SABA) as needed for symptoms
• Preferred option in children 6‐11 is moderate‐dose ICS plus SABA PRN
– Who is it?
• Symptoms and/or awakenings happening almost daily
• Uncontrolled Step 2 despite good technique and adherence
• Risk factor(s) for exacerbations
– What to remember?
• Maintenance + Reliever regimen considered for those ≥ 12 (Not US Approved)
– Budesonide/formoterol or beclomethasone/formoterol
– Reduces exacerbations and provides similar level of symptom control compared to traditional ICS/LABA + SABA PRN
• Adding LABA for adults to same steroid dose
• Increasing steroid dose over adding LABA in children 6‐11
Step‐wise Approach
• Step 4
– What is it?
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Really depends on choice in step 3
Combo medium‐dose ICS/LABA for controller therapy
Short‐acting beta agonists (SABA) as needed for symptoms
Children age 6‐11 should be referred for expert opinion
– Who is it?
• Symptoms and/or awakenings happening almost daily
• Uncontrolled Step 3 despite good technique and adherence
• Risk factor(s) for exacerbations or exacerbations in prior year
– What to remember?
• Maintenance + Reliever low‐dose regimen is more effective in reducing exacerbations than higher dose ICS/LABA traditional therapy for those with exacerbations in the previous year (Not US Approved)
• High‐dose ICS can be given for a short, trial‐basis (3‐6 months), but the increased dose provides little additional benefit with increased risk of side effects
Step‐wise Approach
• Step 5
– These patients need referral to a specialist
– Add‐on therapy should be considered
• Anti‐IgE
• Oral steroids
– Primary care role
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Educate on adherence
Have patient demonstrate inhaler technique Help identify modifiable risk factors
Discuss side‐effects at each encounter
Interface with specialist
Asthma Action Plan
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Assessing Asthma Severity – GINA • Retrospective level of treatment required to control symptoms (after several months of treatment)
• Can be attempted once patient has been stepped down to minimum level of controller treatment needed
• Remember this is not static
• Categories include
– Mild asthma – well controlled with steps 1 or 2
– Moderate asthma – well controlled with step 3
– Severe asthma – requires step 4 or 5 and still may remain uncontrolled
Stepping Up Therapy
• Persisting symptoms and/or exacerbations despite adequate trial of controller therapy (2‐
3 months)
• Before changing therapy, need to assess
– Inhaler technique
– Adherence
– Persistent exposures (allergens or medications)
– Comorbidities
– Diagnosis
Stepping Up Therapy
• Sustained step up
– 2‐3 month change in controller regimen
– If no response, consider referral • Short‐term step up
– 1‐2 weeks in duration increase in ICS
– Useful for situational risk increase (e.g. viral illness)
– Can be initiated by the patient via Asthma Action Plan
• Day‐to‐day adjustment (Not US Approved)
– Used for budesonide/formoterol or beclomethasone/formoterol regimens
– Patient has maintenance dosage and can then take as‐needed doses based on symptoms
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Stepping Down Therapy
• Can/should consider once asthma has been well controlled for at least 3 months and lung function is stable
• Goals:
– Find the minimum effective dose to maintain control
– Continued stress on the importance of controller therapy – patient education
• Stepping down ICS by 25‐50% at 3 month intervals is reasonable and safe for most patients
Asthma Myths Debunked • LABAs need to be stopped ASAP – False – Discontinuing a LABA is more likely to lead to worsening of symptoms (Evidence A)
• Spare ICS when possible – False – Early initiation leads to greater improvement in lung function and overall cumulative ICS dose (i.e. those who wait to start ICS usually require higher doses)
– Completely stopping ICS in adults is not advised due to the increased risk of exacerbations following removal of drug (Evidence A)
– Consider stopping controller only if no symptoms for 6‐12 months, patient has no risk factors, provider gives clear asthma action plan and close follow‐up (Evidence D)
Asthma Myths Debunked • Asthma Action Plans are only for those uncontrolled or brittle despite maximum treatment – False – Effective asthma self management dramatically reduces asthma related morbidity in adults and children (Evidence A)
• Self‐monitoring and/or peak flow
• Written asthma action plan
• Regular review of patient information and control by healthcare provider
• Asthma Inhaler adherence is impossible due to complex regimens and instructions – False
– Many patients can be controlled on once daily ICS opposed to twice daily
• Budesonide, ciclesonide, mometasone all approved for once daily
– Keep eyes open for US labeling of ICS/formoterol maintenance + rescue regimen
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Nonpharmacologic Interventions
• Encourage physical activity
• Avoid exposures or triggers when possible
– Not as a sole treatment plan
• Avoid medications that may exacerbate asthma (risk v. benefit)
– Beta blockers
– NSAIDs
– Aspirin
• Vaccines/health maintenance
• Weight reduction
Stepwise approach – pharmacotherapy
(children ≤5 years)
© Global Initiative for Asthma
GINA 2014, Box 6‐5
© Global Initiative for Asthma
Clinical Comparability in ICS
Children 5 years and younger
Drug
Low
Beclometasone (HFA)
100
Budesonide (nebulized)
200
Fluticasone (HFA)
100
Ciclesonide
160
Triamcinolone
Not studied in this age group
Mometasone
Not studied below 4 years of age
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Patient Profiles
• Tammy is 28 years old and new to your practice
– She recently established primary care after several years of no insurance coverage
– She tells you she was told she had asthma as a child, but does not remember what medications she was given
– She has used albuterol borrowed from her grandmother for the past 3 years and did have one ED visit last spring that required oral steroids
– She is married, they have 1 child, and she works outside the home as a waitress at a local tavern
Patient Profile: Tammy
• What are some of Tammy’s known risks for exacerbations?
• What are some risk factors that need to be explored?
Patient Profile: Tammy
• Based on what information you know about Tammy, what would regimen would you like to initiate?
Presenting Symptoms (without controller medications)
Preferred initial controller
Symptoms or need for SABA < 2 x month
No nighttime awakening in prior month
No risk factors for exacerbations
No exacerbations in previous year
No controller (Evidence D)
Symptoms same as above but ≥ 1 risk factor for exacerbations Low dose ICS (Evidence D)
Symptoms or need for SABA ≤ 2 x week but > 2 x month
Nighttime awakening ≥ 1 x month
Low dose ICS (Evidence B)
Symptoms or need for SABA > 2 x week
Low dose ICS (Evidence A)
LTRA less effective
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Patient Profile: Todd
• Todd is 8 year old child who presents with wheezing and cough during football practice for the past month
– He has no other PMH currently listed
– He lives with his mother, father, and two siblings
– He attends school and social interactions are appropriate for his age
– His weight today is 90 lbs
Patient Profile: Todd
• What questions would you have for Todd or his caregiver?
• Does Todd have asthma?
Patient Profile: Todd
• Assume Todd does have asthma – what regimen/interventions would you begin?
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Patient Profile: Jack
• Jack is a 14 year old adolescent male who is known to your practice and has asthma
– He comes in today with complaints of increased symptoms and night time awakenings
– Has been well‐ controlled on beclomethasone and albuterol PRN for 3 years
– He lives at home with mom, is active in the marching band, and recently started high school
– He is normal height and weight for his age and socially he is introverted and shy
Patient Profile: Jack
• What should be assessed before changing medications for Jack?
• Assuming the need for step‐up therapy, what adjustments would be appropriate?
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