Quality of Life in Daxas-treated Patients Older Than 18 Years With Severe COPD
NCT01285180 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5472
Last updated 2016-10-28
Summary
Daxas (roflumilast) is the first oral anti-inflammatory phosphodiesterase inhibitor (PDE-4) for patients with severe chronic obstructive pulmonary disease (COPD) experiencing chronic cough and sputum and with a history of exacerbations as add-on to bronchodilator treatment. With its mode of action Daxas can reduce exacerbations rates and improve lung function parameters which may result in a better health-related quality of life and an improved long-term management of COPD.
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. Evaluation is based on two COPD specific questionnaires to assess the patient's health status over six months. During the study, socio-demographic data and cost-of-illness data will be recorded. Daxas (tablet) will be administered once daily. The study will provide further data on the safety and tolerability of Daxas.
Conditions
- Severe COPD
Interventions
- DRUG
-
Daxas
500 microgram, oral, once daily as add-on therapy to existing therapy
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
AstraZeneca AstraZeneca · AstraZeneca
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-08-31
- Primary Completion
- 2012-08-31
- Completion
- 2012-08-31
Countries
- Germany
Study Locations
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