NCT00284856

Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,640 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	montelukast sodium	montelukast 10 mg tablet once daily, 6 month treatment period
DRUG	Comparator: Placebo	fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period
DRUG	Comparator: fluticasone	fluticasone propionate 250 mcg twice daily, 6 month treatment period
DRUG	Comparator: Placebo	montelukast 10 mg Pbo tablet once daily, 6 month treatment period

Timeline

• Start date: 2006-05-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2006-02-01
• Last updated: 2024-05-10
• Results posted: 2011-05-03