Daxas
Drug500 microgram, oral, once daily as add-on therapy to existing therapy
NCT Number: NCT01285167
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.
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Notify Me18 year and older
All sexes
Observational
Nycomed Deutschland GmbH, Ahlen, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Main Inclusion Criteria:
Main Exclusion Criteria:
500 microgram, oral, once daily as add-on therapy to existing therapy
Time frame: after 6 months
Evaluation of treatment success by a COPD-specific patient questionnaire
Time frame: after 6 months
Evaluation of treatment success by a health status patient questionnaire
Time frame: after 6 months
Time frame: after 6 months
assessment of adverse drug reactions
Time frame: after 6 months
AstraZeneca
Industry
Daxas for COPD Therapy (DACOTA)
Acronym: DACOTA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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