Quality of Life in Daxas-treated Patients Older Than 18 Years With Severe Chronic Obstructive Pulmonary Disease (COPD) (DACOTA)
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About
Chronic obstructive pulmonary disease (COPD) is a progressive and largely irreversible lung disease characterized by chronic bronchitis and/or emphysema, resulting in breathlessness, cough and sputum. As COPD progresses, patients experience increasing deterioration of their health-related quality of life, with greater impairment in their ability to work and declining participation in social and physical activities.
The aim of this non-interventional study is to evaluate data on quality of life in COPD patients in Germany in a real life medical setting under therapy with the phosphodiesterase-inhibitor (PDE-4) roflumilast (Daxas). Evaluation is based on two COPD specific questionnaires to assess the patient's health status over six months. During the study, lung function measurements such as spirometry will be conducted according to common medical standard. Daxas (tablet) will be administered once daily. The study will provide further data on the safety and tolerability of Daxas.
Enrollment
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Inclusion and exclusion criteria
Main Inclusion Criteria:
- severe COPD
Main Exclusion Criteria:
- Child pugh (classified B and C)
Trial design
3,645 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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