Montelukast Back to School
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: MK0476, montelukast sodium / Duration of Treatment: 8 Weeks (Drug); Comparator: placebo (unspecified) / Duration of Treatment: 8 Weeks (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: percentage of days of worsening asthma over 8-weeks
Secondary outcome: use of rescue medication over 8-weeks, daytime asthma symptoms over 8-weeks, occurrence of health care utilization over 8-weeks
Eligibility
Minimum age: 6 Years.
Maximum age: 14 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male and female non-smoking patients, ages 6 to 14 years, with chronic asthma
- History of at least one asthma exacerbation associated with a cold within the past
year
- Documented history of asthma that required treatment with any asthma medication within
6 months prior to Visit 1
Exclusion Criteria:
- Patient 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
Locations and Contacts
Additional Information
Starting date: June 2006
Last updated: April 13, 2007
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