Montelukast Back to School Asthma Study | RxWiki

Montelukast Back to School Asthma Study

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Asthma
Intervention	Drug: montelukast Drug: Comparator: Placebo
Phase	Phase 3
Sponsor	Merck Sharp & Dohme Corp.
Responsible Party	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier	NCT00461032
First Received	April 13, 2007
Last Updated	May 12, 2010
Last verified	May 2010

Tracking Information[ + expand ][ + ]

First Received Date	April 13, 2007
Last Updated Date	May 12, 2010
Start Date	June 2006
Estimated Primary Completion Date	March 2007
Current Primary Outcome Measures	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] [Designated as safety issue: No]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.
Current Secondary Outcome Measures	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] [Designated as safety issue: No]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] [Designated as safety issue: No] 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] [Designated as safety issue: No]Daytime asthma symptom score was calculated as the sum of the responses (0 (best) to 5 (worst)) to three daytime symptom questions.

Descriptive Information[ + expand ][ + ]

Brief Title	Montelukast Back to School Asthma Study
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
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 Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition	Asthma
Intervention	Drug: montelukast montelukast 5 mg tablet Once a day (QD) for 8 weeks Drug: Comparator: Placebo Placebo to montelukast QD for 8 weeks
Study Arm (s)	Experimental: 1 montelukast Placebo Comparator: 2 Placebo

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	1162
Estimated Completion Date	March 2007
Estimated Primary Completion Date	November 2006
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
Gender	Both
Ages	6 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT00461032
Other Study ID Numbers	2007_539
Has Data Monitoring Committee	No
Information Provided By	Merck Sharp & Dohme Corp.
Study Sponsor	Merck Sharp & Dohme Corp.
Collaborators	Not Provided
Investigators	Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Verification Date	May 2010