aA 12-week double-blind, two-period, multicenter, randomized, placebo-controlled, parallel-group study of 689 children with asthma 2 to 5 years of age; 618 children completed the study.5
bCough, wheeze, and trouble breathing scored on a six-point scale from 0 to 5 (no symptoms to very severe symptoms) daily diary scale; included three of four components of the daytime symptoms score.5
cOvernight symptoms scored on a five-point scale from 0 to 4 (no cough and caregiver not disturbed to coughed all night and caregiver disturbed all night) diary scale.5
dA 12-month double-blind, randomized, placebo-controlled, parallel-group study of 549 children with asthma with a history of episodic asthmatic symptoms resulting from an upper respiratory infection (common cold), lasting at least three days, that led to treatment with beta2-agonists within 12 months before study entry (at least one of the three episodes must have occurred within six months of visit 1). If the patients turned 6 years old during the study, 5 mg tablets were provided.1
eAn exacerbation episode was defined as any three consecutive days with the following two conditions:
- Presence of daytime symptoms (average score of four daily daytime symptom questions of at least 1.0 on each day)
- At least two treatments of beta2-agonist on each day (puffs, tablets, teaspoons, or nebulization treatments) OR
- Rescue use of inhaled corticosteroids (during at least three consecutive days) or oral corticosteroids (during one or more days) OR
- A hospitalization due to asthma.1
Event rate estimated from Poisson regression model.1
Reduction is presented as reduction per year vs. placebo.1
fReduction rate = (1 - relative rate) × 100.1
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