Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05).
- Sponsor
- AstraZeneca
- Study ID
- NCT00242307
- Phase
- PHASE2/PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 20 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Roflumilast — DRUG
Study Details
The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with asthma. Roflumilast will be administered orally once daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.
Key Dates
- Start date
- May 1, 2004
- Status verified
- Jun 2026
- Primary completion
- Sep 1, 2006
- Completion
- Jun 1, 2007
Study Design
- Enrollment
- 450 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Primary Outcome Measure
change in lung function parameters.