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
- asthmaMedDRA version: 8.1Level: LLTClassification code 10003553
- Registration Number
- EUCTR2005-005984-27-AT
- Lead Sponsor
- Merck Sharp & Dohme GesmbH
- Brief Summary
Not available
- Detailed Description
Not available
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?
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)
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
- Secondary Outcome Measures
Name Time Method