Phase 3
Completed N=1,162
Montelukast Back to School Asthma Study (0476-340)
Source: ClinicalTrials.gov NCT00461032 ↗Enrolled (actual)
1,162
Serious AEs
0.4%
Results posted
Feb 2010
Primary outcomePrimary: Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants — 27.23; 24.26 Percentage of Days
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants |
27.23; 24.26 | — |
| SECONDARY Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries) |
70; 55; 406; 411 | — |
| SECONDARY 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 |
7.02; 6.04 | — |
| SECONDARY Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants |
17.4; 16.03 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female non-smoking Participants, ages 6 to 14 years, with chronic asthma, history of at least one asthma exacerbation associated with a cold within the past year and a documented history of asthma that required treatment with any asthma medication within 6 months prior to Visit 1
Exclusion Criteria
- Participant cannot have any other acute or chronic pulmonary disorder, or hospitalization for asthma more than three times within one year prior to signing informed consent
Data sourced from ClinicalTrials.gov (NCT00461032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.