Quality of Life in Daxas-treated Patients Older Than 18 Years With Severe Chronic Obstructive Pulmonary Disease (COPD) (DACOTA)

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Daxas

• Registration Number: NCT01285167
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-01-21
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-27
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2016-09
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3645

Inclusion Criteria

• severe COPD

Main

Exclusion Criteria

• Child pugh (classified B and C)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DACOTA	Daxas	-

Primary Outcome Measures

Name	Time	Method
Pre-/post comparison of the COPD status based on patients health status	after 6 months	Evaluation of treatment success by a COPD-specific patient questionnaire

Secondary Outcome Measures

Name	Time	Method
Effectiveness during treatment	after 6 months	Evaluation of treatment success by a health status patient questionnaire
Pre-/post comparison of spirometry data	after 6 months
Evaluation of tolerability	after 6 months	assessment of adverse drug reactions
Evaluation of symptom reduction of sputum and cough	after 6 months

Trial Locations

Locations (1)

Nycomed Deutschland GmbH; 🇩🇪 Überlingen, Germany