Official Title: “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”

This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in patients with chronic asthma who actively smoke cigarettes.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Study Primary Completion Date: April 2011

Intervention(s) in this Clinical Trial

• Drug: montelukast sodium
  • montelukast 10 mg tablet once daily. 6 month treatment period
• Drug: Comparator: Placebo
  • fluticasone propionate 250 mcg 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Arm 1: Drug
• Active Comparator: 2
  • Arm 2: Active Comparator
• Placebo Comparator: 3
  • Arm 3: Placebo

Primary Measures

• Percentage of asthma-control days over the 6-month treatment period
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• Average change from baseline in mean daytime symptom score over a 6-month treatment period
  • Time Frame: 6 months
    Safety Issue?: No
• Change from baseline in average AM PEFR (peak expiratory flow rate) over a 6-month treatment period
  • Time Frame: 6 months
    Safety Issue?: No

Inclusion Criteria:

• Patients with chronic asthma who actively smoke at least 0.5 to no more than 2 packs of cigarettes a day

Exclusion Criteria:

• Patient can not have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or emphysema.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on March 18, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00284856

Study ID Number: 2005_108

ClinicalTrials.gov Identifier: NCT00284856

Health Authority: Peru: General Directorate of Pharmaceuticals, Devices, and Drugs

MedWatch - FDA maintained medical product safety Information

PhRMA Clinical Study Results Database - web-based repository for clinical study results

Merck: Patient & Caregiver U.S. Product Web Site