NCT01285180

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

Daxas in COPD Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,472 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Daxas	500 microgram, oral, once daily as add-on therapy to existing therapy

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-01-27
• Last updated: 2016-10-28

Locations

2,412 sites across 1 country: Germany