Singulair® In Asthma And Allergic Rhinitis
Information source: Merck
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma, Rhinitis Allergic
Intervention: montelukast sodium (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both
uncontrolled asthma and allergic rhinitis.
Clinical Details
Official title: An 8 Week Study to Evaluate The Effectiveness of Adding Montelukast to Inhaled Corticosteroid (ICS) or to ICS/Long-Acting Beta 2-Agonist Therapy in Adult Subjects With Asthma and Allergic Rhinitis
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Canadian guideline asthma control definition
Secondary outcome: Asthma Control Questionnaire, Mini-RQLQ
Eligibility
Minimum age: 15 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Merck Frosst Canada Ltd., Kirkland, Quebec H9H 3L1, Canada; Recruiting
Francois Bertrand, Phone: 1-514-428-2641
Additional Information
(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)
Starting date: April 2007
Ending date: August 2008
Last updated: August 6, 2008
|
