Quality of Life in Daxas-treated Patients Older Than 18 Years With Severe COPD

Completed

• Conditions: Severe COPD
• Interventions: Drug: Daxas

• Registration Number: NCT01285180
• Lead Sponsor: AstraZeneca

Brief 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.

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: 2012-08
• Study Completion: 2012-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5472

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
DINO	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
Evaluation of tolerability	after 6 months	assessment of adverse drug reactions
Evaluation of symptom reduction of sputum and cough	after 6 months
Effectiveness during treatment	after 6 months	Evaluation of treatment success by a health status patient questionnaire
Evaluation of cost-of-illness data	before treatment	number of consultations, sick leave, hospitalisation, number of and duration of rehab measures
Evaluation of sociodemographic data	before treatment	employment status, disease management programme

Trial Locations

Locations (1)

Nycomed Deutschland GmbH; 🇩🇪 Übach-Palenberg, Germany