First Step With Singulair® Therapy (0476-323)
Phase 4
Completed
- Conditions
- Asthma
- Registration Number
- NCT00545324
- Lead Sponsor
- Organon and Co
- Brief Summary
In adult patients with mild persistent asthma, singulair® 10 mg will be at least as effective as low dose Inhaled Corticosteroids (ICS) in improving asthma symptom control or satisfaction over a 6 week comparison period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 399
Inclusion Criteria
- First time diagnosis of mild asthma symptoms which requires an antiinflammatory controller medication
- Patients not controlled with short acting beta2 agonist (sab) therapy (requiring more than one treatment per week but less than 7 per week)
- Patients dissatisfied with low dose ics therapy, or patients reluctant to take ics therapy, or patients insufficiently controlled due to non-compliance with low dose ics therapy through out the preceding 6 weeks
- Patient's forced expiratory volume in one second (fev1) is < 80% of predicted value
Exclusion Criteria
- Patient on combination therapy
- Patient on long acting beta2 agonists
- Patient on using moderate to high doses of ICS. (ICS >250 µ g/day flovent® or equivalent per day)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Canadian asthma guidelines criteria
- Secondary Outcome Measures
Name Time Method Asthma control questionnaire