Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07)
Status and phase
Completed
Phase 3
Conditions
Bronchial Asthma
Treatments
Drug: Roflumilast
Details and patient eligibility
About
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.
Sex
All
Ages
20 to 71 years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion criteria
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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