Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08)
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The aim of this long-term study is to investigate the effect of roflumilast (APTA-2217) on the long-term safety in patients with chronic obstructive pulmonary disease (COPD) who completed the 24-week evaluation of study APTA-2217-06. Roflumilast will be administered orally once daily. The present study consists of a 28 weeks treatment period, and is an extension of the 24-week study APTA-2217-06 (registered study). The study will provide further long-term safety and efficacy data of roflumilast.
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Layout table for eligibility information
Ages Eligible for Study:
40 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Main inclusion criteria:
Patients with chronic obstructive pulmonary disease (COPD)
Written informed consent
Patients who completed the 24-week evaluation of study APTA-2217-06
Main exclusion criteria:
If patients required hospitalization or received emergency care for COPD exacerbation by the investigator (or sub-investigator) between the informed consent day and the starting day