Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07)
Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07)
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.
Main inclusion criteria:

 -  Patients with asthma disease

 -  Written informed consent

 -  Patients who completed the 24-week evaluation of study APTA-2217-05

 Main exclusion criteria:

 -  % FEV1.0 < 60% at both 18 weeks and 24 weeks measurements during APTA-2217-05

 -  Patients with poorly controlled asthma between informed consent day and study starting
 day: need for oral or intravenous steroid therapy, hospitalization or any emergency
 visit, PEF value worsened for 2 or more consecutive days

 -  Serious diseases