At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,640 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, Double-Blind, Parallel-Group 6-Month Study to Evaluate the Efficacy and Safety of Oral Montelukast Sodium, Fluticasone Propionate and Placebo in Patients With Chronic Asthma Who Smoke Cigarettes
In Brief
A Phase 3 clinical trial evaluating montelukast sodium, Comparator: Placebo, and 1 other intervention for Asthma. Completed, enrolled 1,640 participants.
Detailed Summary
This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in participants with chronic asthma who actively smoke cigarettes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2006
Enrollment StartMay 2006
Primary CompletionApr 2010
TodayJul 2026
First PostedFeb 1, 2006
Enrollment StartMay 1, 2006
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 20.4 years ago
Interventions
montelukast sodiumdrug
montelukast 10 mg tablet once daily, 6 month treatment period
Comparator: Placebodrug
fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period
Comparator: fluticasonedrug
fluticasone propionate 250 mcg twice daily, 6 month treatment period
Comparator: Placebodrug
montelukast 10 mg Pbo tablet once daily, 6 month treatment period