Montelukast Back to School Asthma Study (0476-340)

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: montelukast

• Registration Number: NCT00461032
• Lead Sponsor: Organon and Co

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Study First Submitted: 2007-04-13
• Study First Submitted QC: 2007-04-13
• Study First Posted: 2007-04-17
• Results First Submitted: 2010-01-12
• Results First Submitted QC: 2010-01-12
• Results First Posted: 2010-02-04
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1162

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	montelukast	montelukast

Primary Outcome Measures

Name	Time	Method
Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants	8 Week treatment period initiated at the beginning of a school year	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries)	8 Week treatment period initiated at the beginning of a school year	Health care utilization is defined as unanticipated asthma care in an office or clinic, emergent or hospital setting.
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	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	8 Week treatment period initiated at the beginning of a school year	Daytime asthma symptom score was calculated as the sum of the responses (0 (best) to 5 (worst)) to three daytime symptom questions.