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

Verified by: Merck, April 2011
First Received: January 31, 2006 | Last Updated: April 6, 2011 | Phase: Phase 3 | Start Date: May 2006
Overall Status: Completed | Estimated Enrollment: 1640
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This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in participants with chronic asthma who actively smoke cigarettes...

Brief Summary

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 participants with chronic asthma who actively smoke cigarettes.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: April 2010

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 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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Arm 1: Montelukast
  • Active Comparator: 2
    • Arm 2: Fluticasone
  • Placebo Comparator: 3
    • Arm 3: Placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Percentage of Asthma-control Days Over the 6-month Treatment Period
    • Time Frame: 6 months
      Safety Issue?: No

Secondary Measures

  • Change From Baseline in Mean Daytime Symptom Score Over a 6-month Treatment Period
    • Time Frame: Baseline and 6 months
      Safety Issue?: No
  • Change From Baseline in Average Morning (AM) PEFR (Peak Expiratory Flow Rate) Over a 6-month Treatment Period
    • Time Frame: Baseline and 6 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

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

Exclusion Criteria:

  • Participant cannot 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

Clinical Trial Investigator Information

Lead Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

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

Study ID Number: MK-0476-332

ClinicalTrials.gov Identifier: NCT00284856

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

MedWatch - FDA maintained medical product safety Information

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00284856