At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 642 enrolled
Drug / intervention
montelukast sodium +3 moredrug
Likely dose
montelukast sodium 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, 2-Period, Parallel-Group Study to Assess the Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients
In Brief
A Phase 3 clinical trial evaluating montelukast sodium, beclomethasone, and 2 other interventions for Asthma. Completed, enrolled 642 participants.
Detailed Summary
This study will investigate the additive effect of montelukast (MK0476) taken along with inhaled beclomethasone versus inhaled beclomethasone alone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 1995
Primary CompletionApr 1996
Study CompletionMay 1996
First PostedJun 2009
TodayJul 2026
First PostedJun 2, 2009
Enrollment StartMar 1, 1995
Primary CompletionApr 1, 1996
Study CompletionMay 1, 1996
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.1 years ago
Interventions
montelukast sodiumdrug
10 mg tablet taken once daily at bedtime for 16 weeks
beclomethasonedrug
200 ug inhaled, taken twice daily for 16 weeks
Placebo inhalerdrug
placebo inhaler taken twice daily for 16 weeks
placebo tabletdrug
placebo tablet taken once daily at bedtime for 16 weeks