Singulair(R) In Asthma And Allergic Rhinitis
Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both uncontrolled asthma and allergic rhinitis...
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”
Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both uncontrolled asthma and allergic rhinitis.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- 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
- Asthma Control
- Time Frame: 8 weeks (from Week 0 to Week 8)
Safety Issue?: No
- Time Frame: 8 weeks (from Week 0 to Week 8)
Secondary Measures
- The Mean Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Score
- Time Frame: 8 weeks (from Week 0 to Week 8)
Safety Issue?: No
- Time Frame: 8 weeks (from Week 0 to Week 8)
- Effectiveness of Montelukast Therapy Used in Combination With Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist in Improving the Symptoms of Asthma Using the Asthma Control Questionnaire (ACQ)
- Time Frame: 8 weeks (from Week 0 to Week 8)
Safety Issue?: No
- Time Frame: 8 weeks (from Week 0 to Week 8)
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patient is a user of Inhaled Corticosteroid (ICS) or ICS/Long-Acting Beta 2-Agonist (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 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/NCT00545844
Study ID Number: 2007_024
ClinicalTrials.gov Identifier: NCT00545844
Health Authority: Canada: Health Canada
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00545844
