Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07).
- Sponsor
- AstraZeneca
- Study ID
- NCT00246922
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 20 Years - 71 Years
- Healthy Volunteers
- Not accepted
Interventions
- Roflumilast — DRUG
Study Details
The aim of this long-term study is to investigate the effect of roflumilast (APTA-2217) on the long-term safety in patients with asthma, who completed the 24-week evaluation of study APTA-2217-05. Roflumilast will be administered orally once daily. The present study consists of a 28 weeks treatment period, and is the extension of the 24-week study APTA-2217-05 (registered study). The study will provide further long-term safety and efficacy data of roflumilast.
Key Dates
- Start date
- Dec 1, 2004
- Status verified
- Jun 2026
- Primary completion
- Jan 1, 2007
- Completion
- Oct 1, 2007
Study Design
- Enrollment
- 150 participants
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Primary Outcome Measure
Long-term safety after 28 weeks treatment of Roflumilast at (total 52 weeks, 24 weeks of study APTA-2217-05 followed by 28 weeks) .