Patient Registry of Roflumilast In Real Life
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About
A patient registry to capture real life data and demonstrate the performance of roflumilast (Daxas®) in a standard clinical practice.
Full description
The drug being tested in this observational study design is called roflumilast, but not as an therapeutic intervention. Roflumilast is approved for and marketed globally for maintenance treatment of severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.
This study will capture real life data and demonstrate the performance of roflumilast in a standard clinical practice. The study will enroll approximately 1350 (EU)+600(North Asia) patients. This multi-centre trial will be conducted in at least 4 EU and 2 North Asian countries.
The overall time to participate in this study is 12 months. No visits, diagnostic procedures or monitoring will take place, which would not happen had the patient not been included in the study.
Participants will be followed according to usual practice and data recorded approximately at 6 months and at 12 months of roflumilast treatment.
Enrollment
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Inclusion criteria
- Signed informed consent to the data collection
- Roflumilast (Daxas®) treatment initiated in Roflumilast (Daxas®) naïve patients at the time of registry
Exclusion criteria
There are no exclusion criteria per se. However it is expected that patients are treated according to locally approved marketing authorisation.
Trial design
1,950 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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