Trials / Completed
CompletedNCT00242307
Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05)
A Confirmatory Study of APTA-2217 in Adult Patients With Bronchial Asthma (A Placebo-controlled Double-blind Comparative Study)
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 450 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 20 Years – 70 Years
- Healthy volunteers
- —
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Roflumilast |
Timeline
- Start date
- 2004-05-01
- Primary completion
- 2006-09-01
- Completion
- 2007-06-01
- First posted
- 2005-10-20
- Last updated
- 2026-02-18
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT00242307. Inclusion in this directory is not an endorsement.