Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05)
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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.
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Ages Eligible for Study:
20 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:
Main inclusion criteria:
Adult patients with bronchial asthma meeting the Guideline for Prevention and Control of Asthma 2003 (JGL 1998, revised 2nd edition)
No change in asthma treatment during the last 4 weeks prior to the registration
Non-smokers or ex-smokers for 12 months or more
%FEV1 ranging between 60 and 80%
Main exclusion criteria:
Patients with poorly controlled asthma
Inhalation therapy exceeding low dose during 4 weeks prior to the registration
Concurrent respiratory diseases such as COPD considered to affect the efficacy evaluation