TM Pediatric Asthma Evaluation & Management Bradley E. Chipps, MD, FAAP Capital Allergy &...

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Pediatric Asthma Evaluation & Management

Bradley E. Chipps, MD, FAAPCapital Allergy & Respiratory Disease CenterSacramento, CA

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Prepared for your next patient.

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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.

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Definition of AsthmaA 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

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Diagnosis1. History

2. Pulmonary function tests (PFTs)

3. Challenge studies

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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.

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Cough—Asthma?Consider asthma in children with:Recurrent episodes of cough with or without wheezingNocturnal awakening because of coughCough that is associated with exercise/playCough without wheeze is often not asthma

Cough may be the only symptompresent in patients with asthma.

Goldsobel AB, Chipps BE. Cough in the pediatric population. J Pediatr. 2010;156(3):352–358

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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

OR One major criterion• Parent with asthma• Atopic dermatitis• Aero-allergen

sensitivity

Two minor criteria• Food sensitivity• Peripheral

eosinophilia (≥4%) • Wheezing not

related to infectionModified 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

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Objective Evaluation of Asthma Physical examination

Pulmonary function

Bronchoprovocation

Validated control tools

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Defining Asthma Severity and Control

1) 0–4 years

2) 5–11 years

3) 12 years and older

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How Can Asthma Control Be Measured?

AsthmaControl

Inflammation?Direct or indirect?

Lung function? Daytime

symptoms?

Utilization of healthcare resources?

Nighttime awakenings?

Functional status?

Missed work and/or school?

Patient self-report of control?

Use of “quick relief” inhaler

and/or nebulizer?

Asthma control test is a trademark of QualityMetric Incorporated.

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Asthma Control Cannot be Assessedat a Single Time Point

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 beta2-agonists. J Pediatr. 2006;148(4):517–521; Calhoun WJ, Sutton LB, Emmett A, et al. Asthma variability in patients previously treated with beta2-agonists alone. J Allergy Clin Immunol. 2003;112(6):1088–1094

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Number of Changes Over Weeks 1–12

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Classifying Asthma Severity and InitiatingTreatment 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

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Assessing Asthma Control and AdjustingTherapy in Children 0 to 4 Years of Age


TMTest for Respiratory and Asthma Control in Kids (TRACK)

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Stepwise Approach for Managing Asthma in Children 0 to 4 Years of Age


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Classifying Asthma Severity and InitiatingTreatment in Children 5 to 11 Years of Age

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Assessing Asthma Control and Adjusting Therapy in Children 5 to 11 Years of Age

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Childhood Asthma Control Test™

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Stepwise Approach for Managing Asthmain 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 andManagement of Asthma. US Department of Health and Human Services. Available at: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf. Accessed July 5, 2012

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Classifying Asthma Severity and InitiatingTreatment in Youth ≥12 Years of Age and Adults

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Assessing Asthma Control in Children≥12 Years of Age and Adults

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Asthma Control Test™ (ACT)

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Stepwise Approach for Managing Asthmain Children 12 Years of Age and Adults

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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

eczemaOr 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

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Step-down TherapyStep down once control is achieved:After 2–3 months25% reduction over 2–3 months

Follow-up monitoring:Every 1–6 monthsAssess symptoms.Review medication use.Objective monitoring (PEF or spirometry)Review medication.

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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.

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Phenotypic Expressions of ChildhoodWheezing Disorders

1. Viral induced wheezing

2. Severe intermittent wheezing

3. Exercise bronchospasm/asthma

4. Persistent asthma

5. Severe asthma

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Viral Induced Wheezing

1. Triggered by viral infections

2. Non-atopic

3. Remission in childhood

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Infants

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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

TMIntermittent ICS in Infants:Withdrawal Due to Persistent Wheezing

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Days after Randomization

Budesonide

Placebo

P=0.41

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

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Role of Viral Infections

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Rhinovirus (RV) Wheezing versusRespiratory 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

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Forced Expiratory Volume in 1 Second (FEV1)Percent Predicted

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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.

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Oral Prednisolone for Preschool Childrenwith 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

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Severe IntermittentWheezing

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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 systemiccorticosteroids

TMEpisodic Use of an ICS or LTRA in Preschool Childrenwith Moderate-to-Severe Intermittent Wheezing

Montelukast 4 mg daily + Placebo ICS + -agonist

At first sign of RTI symptoms x 7 days

Study Overview

Budesonide 1 mg bid+ Placebo LTRA + -

agonist

RandomizationRun in

Acute Intermittent Management Strategies (AIMS)

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)

useBacharier 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

Placebo LTRA + Placebo ICS + -agonist

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1° Outcome—Mean Proportion ofEpisode Free Days

Proportion of episode free days adjusted for age group, API status, center

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Maintenance versus Intermittent InhaledSteroids 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

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Run-in: 2 weeks Treatment Phase: 52 weeks

Pbo run-in nightly +

Albuterol PRN

Randomized

Treatment Group

Nightly, except during RTI

During RTIs only for 7 days

Daily low dose budesonide

0.5 mg PM Pbo AM

0.5 mg PM

Intermittent high dose budesonide

Pbo PM 1.0 mg AM

1.0 mg PM

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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

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Diagnosis of Exercise-induced Bronchospasm (EIB) / Exercise-

induced Asthma (EIA)

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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.

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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

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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

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Persistent Asthma

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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

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The Prevalence of Wheezing VariesDepending on Age and Atopic Status

Atopic (n=94)Non-atopic (n=59)

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Age (years)

Prevalence (%)

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

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Time of Sensitization and Degree of Exposure to Indoor Allergens and Lung Function Impairment at 7 Years of Age

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FEV1

(% pred)

MEF50

(% pred)

NS S/LE S/HE NS S/LE S/HE

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700

105

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p=0.009 p=0.003

FEV1 (% pred)

MEF50 (% pred)

NS S/LE S/HE NS S/LE S/HE

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

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Melbourne Epidemiological Study

Phelan PD, Robertson CF, Olinsky A. The Melbourne Asthma Study: 1964-1999. J Allergy Clin Immunol. 2002;109(2):189–194

TMA Longitudinal, Population-based, Cohort Studyof Childhood Asthma Followed to Adulthood

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

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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

TMFluticasone Had No Carryover EffectDuring the Observation Period

p=0.006 p=0.781.00

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Treatment Period Observation Period

0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36

Months

The increase in symptom free days in the fluticasone cohort during the treatment period waslost 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

Fluticasone

Placebo

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The Need for Oral CorticosteroidsAll Children Children Not Receiving

Supplementary MedicationObservation

Treatment

Fluticasone

Placebo

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No. at Risk

Fluticasone 143 102 80 66 57 42

Placebo 142 87 62 57 50 41

No. at Risk

Fluticasone 132 88

Placebo 130 85

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The Need for Supplementary Controller Meds:No Difference at 36 months

No. at Risk

Fluticasone 143 131 118 116 113 99

Placebo 142 125 103 99 93 86

No. at Risk

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), thegroups were indistinguishable (P=0.99)


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Changes in Height from Baseline and Between Groups

Change in height from baseline represented by the panel on the left. The difference betweengroups 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.


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Month 1 4 8 12 16 20 24 28 32 36

P value 0.81

0.07

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<0.001

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03

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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.

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START

INHALED STEROID TREATMENTAS 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

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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

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Double-blind (Part A) andOpen-label (Part B) Design

AdultsPulmicort 400 g once daily

+ usual asthma therapyChildren (6–10 y of age)

Pulmicort 200 g once daily+ usual asthma therapy

Part A – Pulmicort therapy

Part B: Open-label

Part A – Reference therapy

AdultsPulmicort 400 g once daily

+ usual asthma therapy

Children (6–10 y of age)Pulmicort 200 g once daily

+ usual asthma therapyAdults and Children

Placebo once daily + usual asthma therapy

Year 0 1 2 3 4 5Visit 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22

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Time to First SARE44% (95% CI, 29–55%) reduced risk of first SARE*


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Reference therapyBudesonide therapy

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*Hazard ratio = 0.56; P<.0001.

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Patients Requiring Additional Corticosteroids*

*Inhaled, oral, or systemic


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Budesonide Therapy Reference Therapy

% o

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Changes in Postbronchodilator FEV1 Over 3 Years


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Early Intervention with Budesonide inMild 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

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Early Intervention with Budesonide inMild 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 medicationPauwels 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

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BADGER Trial

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BADGER Trial1. 182 children (6–17 years of age), uncontrolled

asthma, FP 100 µg BID, triple crossover design,16-week period

2. FP 250 µg BIDFP 100 µg + SALM 50 µg BIDFP 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

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Primary Predictors of a DifferentialResponse to Step-up Therapy


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Secondary Predictors of a DifferentialResponse to Step-up Therapy


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Enrollment, Outcomes, and Schedule of Evaluations


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Pairwise Comparisons


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Probability of Best Response


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Severe Asthma

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Severe Asthma Refractory

Difficult to control asthma

Uncontrolled asthma refractory to conventional treatment

Frequent exacerbations

? Distinct phenotype or subgroup

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Reasons for Failure to Achieve Control Compliance

Asthma heterogeneity

Wrong diagnosis

Wrong target

Failure to deliver drug to the target site

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Demographic and clinicalcharacteristics of children

and adolescents with severe ordifficult-to-treat asthma

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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

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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.

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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)

Males(N=791)

n (%)

Females(N=470)

n (%)

Total(N=1,261)

n (%)6-8 145 (18) 88 (19) 233 (18)

9-11 282 (36) 120 (26) 402 (32)12-14 240 (30) 171 (36) 411 (33)15-17 124 (16) 91 (19) 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

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Spirometry by Age and Gender


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Medication Use by Age

*Based on test for linear trend, a statistically significant age trend (P <.05) was seen for methylxanthines and long-acting -agonists.


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Healthcare Utilization by Long-term Controller Use:6–11 and 12–17 Years of Age


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Summary―Predicting Persistence of Wheezing1. 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 ?

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Thank You

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TM Pediatric Asthma Evaluation & Management Bradley E. Chipps, MD, FAAP Capital Allergy &...

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Transcript of TM Pediatric Asthma Evaluation & Management Bradley E. Chipps, MD, FAAP Capital Allergy &...