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: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

• Drug: montelukast sodium
  • montelukast 10 mg tablet once daily. 6 month treatment period
• Drug: Comparator: fluticasone
  • fluticasone propionate 250 mg bid twice daily, 6 month treatment period.
• Drug: Comparator: Placebo (unspecified)
  • montelukast 10 mg Pbo tablet once daily, 6 month treatment period.
• Drug: Comparator: Placebo (unspecified)
  • fluticasone propionate 250 mg Pbo tablet bid twice 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

• Evaluate the treatment effect on asthma-control days at 6 months.
  • Time Frame: 6 Months
    Safety Issue?: No

Secondary Measures

• Patient can not have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or emphysema.
  • 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 August 29, 2008

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)