A Clinical Study of Oglemilast in Patients With Mild to Moderate Persistent Asthma
- Registration Number
- NCT00859404
- Lead Sponsor
- Glenmark Pharmaceuticals Europe Ltd. (R&D)
- Brief Summary
The study is aimed at evaluating efficacy and safety of oglemilast in the treatment of stable mild to moderate persistent asthma. The study involves two weeks of run in period. This is a placebo controlled study. One of the four treatment arms is placebo. The duration of treatment is 12 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 282
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1. oglemilast oglemilast - 3. oglemilast oglemilast - 4. placebo oglemilast - 2. oglemilast oglemilast -
- Primary Outcome Measures
Name Time Method Morning pre-dose FEV1 at day 85 compared with pre-dose FEV1 value at day 1 12 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline at days 8, 36 and 64 in morning pre-dose FEV1 Days 8, 36, 64 Change from baseline at days 8, 36 and 64 in morning pre-dose vital capacity (FVC), peak expiratory flow (PEF), forced expiratory flow 25-75% (FEF25-75%) days 8, 36 and 64 Change from baseline in morning and evening PEF (based on patient diary) 12 weeks Change in asthma day time symptom score from baseline at day 85 12 weeks Change in asthma night time symptom score from baseline at day 85 12 weeks Change in number of night time awakenings from baseline at day 85 12 weeks Frequency and the use of rescue (reliever) medication (salbutamol) 12 weeks Frequency and severity of asthma exacerbations 12 weeks Investigator global impression of change from baseline to day 85 12 weeks Patient global impression of change from baseline to day 85 12 weeks Pharmacokinetic parameters of oglemilast 12 weeks
Trial Locations
- Locations (1)
Glenmark investigational sites (28)
🇮🇳Mumbai, Bangalore etc, India