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 - Montelukast Asthmatic Smoker Study

• Conditions: asthma; MedDRA version: 8.1Level: LLTClassification code 10003553

• Registration Number: EUCTR2005-005984-27-LT
• Lead Sponsor: Merck & Co., Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

Patient is a male or female 18-55 years inclusive. Consistent clinical history of chronic asthma. Cigarette smokers with a smoking history of 30 pack year history or less. Patient has a defined range of FEV1, evidence of reversibility airway obstruction and reached a predetermined level of baseline beta-agonist use during the run in period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient has diagnosis of Chronic Obstructive Pulmonary Disease and/or emphysema.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the treatment effect of montelukast 10 mg vs. placebo in asthmatic patients who smoke cigarettes, over a 6 month treatment period on the percentage of asthma-control days. ;Secondary Objective: In asthmatic patients who smoke cigarettes after 6 months of treatment: To compare the treatment effect of montelukast 10mg vs. fluticasone propionate 250 mcg bid. To compare the treatment effect of fluticasone propionate 250 mcg bid vs placebo. Determine the safety and tolerability of montelukast 10mg and fluticasone propionate 250 mcg bid.;Primary end point(s): Asthma Control Day: any day with no unscheduled visit for asthma care to an office, emergent or hospital setting, no use of more than 2 puffs of beta agonist, no use of other asthma rescue medication and no nocturnal awakening.