Bronchial Asthma
Conditions
Keywords
Asthma, Roflumilast, phosphodiesterase 4 inhibitor
Brief 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.
Interventions
DRUGRoflumilast
Sponsors
AstraZeneca
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to 71 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long-term safety after 28 weeks treatment of Roflumilast at (total 52 weeks, 24 weeks of study APTA-2217-05 followed by 28 weeks) . | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy. | — |
Countries
Japan
Contacts
STUDY_DIRECTORAstraZeneca AstraZeneca
AstraZeneca
Outcome results
None listed