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.
Study Type
OBSERVATIONAL
Enrollment
5,472
500 microgram, oral, once daily as add-on therapy to existing therapy
Nycomed Deutschland GmbH
Aachen, Germany
Nycomed Deutschland GmbH
Aachen, Germany
Nycomed Deutschland GmbH
Aachen, Germany
Nycomed Deutschland GmbH
Aachen, Germany
Nycomed Deutschland GmbH
Aalen, Germany
Nycomed Deutschland GmbH
Aalen, Germany
Pre-/post comparison of the COPD status based on patients health status
Evaluation of treatment success by a COPD-specific patient questionnaire
Time frame: after 6 months
Effectiveness during treatment
Evaluation of treatment success by a health status patient questionnaire
Time frame: after 6 months
Evaluation of tolerability
assessment of adverse drug reactions
Time frame: after 6 months
Evaluation of cost-of-illness data
number of consultations, sick leave, hospitalisation, number of and duration of rehab measures
Time frame: before treatment
Evaluation of sociodemographic data
employment status, disease management programme
Time frame: before treatment
Evaluation of symptom reduction of sputum and cough
Time frame: after 6 months
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Nycomed Deutschland GmbH
Abensberg, Germany
Nycomed Deutschland GmbH
Achern, Germany
Nycomed Deutschland GmbH
Achim, Germany
Nycomed Deutschland GmbH
Adelebsen, Germany
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