Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Patient Registry of Roflumilast In Real Life
A patient registry to capture real life data and demonstrate the performance of roflumilast (Daxas®) in a standard clinical practice.
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.
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