Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both uncontrolled asthma and allergic rhinitis...
Date First Received: October 16, 2007
Last Updated: October 30, 2008
Verified by: Merck, October 2008
Clinical Trial Phase: Phase 4 | Start Date: April 2007
Overall Status: Completed
Estimated Enrollment: 440
Brief Summary
Official Title: “An 8 Week Study to Evaluate the Effectiveness of Adding Montelukast to Inhaled Corticosteroid (ICS) to the ICS/Long-Acting Beta 2-Agonist Therapy in Adult Subjects With Asthma and Allergic Rhinitis”
Condition Keyword(s):
Intervention(s):
Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both uncontrolled asthma and allergic rhinitis.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Study Primary Completion Date: January 2008
Intervention(s) in this Clinical Trial
- Drug: montelukast sodium
- montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- montelukast sodium
Outcome Measures for this Clinical Trial
Primary Measures
- Canadian guideline asthma control definition
- Time Frame: 8 Weeks
Safety Issue?: No
- Time Frame: 8 Weeks
Secondary Measures
- Asthma Control Questionnaire, Mini-RQLQ
- Time Frame: 8 Weeks
Safety Issue?: No
- Time Frame: 8 Weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patient is a user of ICS or ICS/LABA at any dosage
- Peak expiratory flow is > or = 80% of predicted value on the day of visit 1
- Uncontrolled as per Canadian asthma consensus guidelines
Exclusion Criteria:
- Unwilling to stop regular use of histamine H1 antagonists for allergic rhinitis symptoms
- Unwilling to stop use of antihistamine eye drops or cromoglycate eye drops or ophthalmic corticosteroid
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 15 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00545844
Study ID Number: 2007_024
ClinicalTrials.gov Identifier: NCT00545844
Health Authority: Canada: Health Canada
MedWatch - FDA maintained medical product safety Information
PhRMA Clinical Study Results Database - web-based repository for clinical study results
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