SINGULAIR (R) as Complementary Therapy to Fixed Association Regimen (0476-363)
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00445107
- Lead Sponsor
- Organon and Co
- Brief Summary
The purpose of this study is to assess the treatment effect of montelukast 10mg on the primary endpoint of Asthma Control Questionnaire(ACQ), over a 8-week period, in persistent asthma patients with or without allergic rhinitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 198
Inclusion Criteria
- Patient is currently a nonsmoker and has been a nonsmoker for at least 1 year
- Patient with clinical evidence of mild/moderate asthma with or without allergic rhinitis
Exclusion Criteria
- Patient has been treated in an emergency room for asthma within 4 weeks or has been hospitalized for asthma within 3 months prior to visit 1
- Patient with severe asthma, upper respiratory infection, sinusitis, infectious rhinitis, non-allergic rhinitis
- Patient has any active, acute, or chronic pulmonary disorder that is documented by history, physical examination
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change of the asthma control questionnaire scores taken over 8 weeks
- Secondary Outcome Measures
Name Time Method