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Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07).
Sponsor: AstraZeneca
Summary
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.
Official title: A Long-term Study of APTA-2217 in Adult Patients With Bronchial Asthma
Key Details
Gender
All
Age Range
20 Years - 71 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2004-12-01
Completion Date
2007-10-01
Last Updated
2026-06-10
Healthy Volunteers
No
Conditions
Interventions
Roflumilast
Locations (1)
Nycomed Japan and Mitsubishi Tanabe Pharma Corporation
Osaka, Japan