Montelukast Back to School Asthma Study (0476-340)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00461032|
Recruitment Status : Completed
First Posted : April 17, 2007
Results First Posted : February 4, 2010
Last Update Posted : March 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: montelukast Drug: Comparator: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1162 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, Randomized, Double-blind, Placebo-Controlled Parallel Group 8-week Study to Evaluate the Efficacy and Safety of Chewable Montelukast When Initiated at the Start of the School Year in Pediatric Patients With Chronic Asthma|
|Study Start Date :||June 2006|
|Primary Completion Date :||November 2006|
|Study Completion Date :||November 2006|
montelukast 5 mg tablet Once a day (QD) for 8 weeks
Placebo Comparator: 2
Drug: Comparator: Placebo
Placebo to montelukast QD for 8 weeks
- Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants [ Time Frame: 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.
- Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries) [ Time Frame: 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 [ 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00461032
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|