Official Title: “Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma”

This study assesses inhaled corticosteroid plus montelukast compared with inhaled corticosteroid therapy alone for treatment of patients with chronic asthma.

Study Type: Interventional

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

Study Primary Completion Date: December 2008

During this study, all patients will receive mometasone (powder, 220 ug once-daily, for approximately 6 weeks). In a crossover manner, eligible patients will also receive montelukast (powder, 1 mg once-daily, for approximately 2 weeks) followed by placebo; or will receive placebo followed by montelukast. The order of when each of these 2 treatments are added to the mometasone will be randomized.

Intervention(s) in this Clinical Trial

• Drug: Comparator: mometasone
  • montelukast (inhalation powder, 220 ug once-daily, for approximately 6 weeks)
• Drug: Comparator: montelukast
  • montelukast (inhalation powder, 1 mg once-daily, for approximately 2 weeks)
• Drug: Comparator: placebo (unspecified)
  • Placebo (Placebo once-daily, for approximately 2 weeks)

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • mometasone
• Placebo Comparator: 2
  • montelukast followed by placebo; or placebo followed by montelukast.

Primary Measures

• FEV1 (Forced Expiratory Volume; volume of air that is exhaled during the first second of a forced exhalation)
  • Time Frame: 2 Weeks
    Safety Issue?: No

Secondary Measures

• asthma symptoms
  • Time Frame: 2 Weeks
    Safety Issue?: No

Inclusion Criteria:

• Within one month of the first study visit, patient has been treated with a fast-acting asthma inhaler, and may be treated with a corticosteroid inhaler or an inhaler that combines a corticosteroid plus a bronchodilator
• Patient has decreased breathing capacity (when not taking asthma medicine) that improves after taking a fast-acting asthma inhaler

Exclusion Criteria:

• Patient is hypersensitive to inhaled beta-agonists, corticosteroids, leukotriene antagonists, or any of their components
• Patient has required an oral corticosteroid rescue for worsening asthma during the screening period
• Patient has taken aspirin and nonsteroidal anti-inflammatory medication in patients known to be sensitive OR patient has not had previous exposure to these compounds

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 15 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Overall Contact: Toll Free Number 1-888-577-8839 

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00666679

Study ID Number: 2007_654

ClinicalTrials.gov Identifier: NCT00666679

Health Authority: United States: Food and Drug Administration

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