This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,162
montelukast 5 mg tablet Once a day (QD) for 8 weeks
Placebo to montelukast QD for 8 weeks
Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
A day of worsening asthma is a day with: increase from baseline in β-agonist use (\> 70% and a min increase of 2 puffs); \> 50% increase from baseline in daytime symptoms score; awake "all night"; increase from baseline in inhaled corticosteroid use ≥ 100% or oral corticosteroid rescue for worsening asthma; or unanticipated healthcare utilization.
Time frame: 8 Week treatment period initiated at the beginning of a school year
Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries)
Health care utilization is defined as unanticipated asthma care in an office or clinic, emergent or hospital setting.
Time frame: 8 Week treatment period initiated at the beginning of a school year
Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
Time frame: 8 Week treatment period initiated at the beginning of a school year
Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
Daytime asthma symptom score was calculated as the sum of the responses (0 (best) to 5 (worst)) to three daytime symptom questions.
Time frame: 8 Week treatment period initiated at the beginning of a school year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.