Severe COPD
Conditions
Keywords
COPD, Quality of life, sociodemographic data, cost-of-illness data, roflumilast, Daxas
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.
Interventions
DRUGDaxas
500 microgram, oral, once daily as add-on therapy to existing therapy
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * severe COPD Main
Exclusion criteria
* Child pugh (classified B and C)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness during treatment | after 6 months | Evaluation of treatment success by a health status patient questionnaire |
| Evaluation of tolerability | after 6 months | assessment of adverse drug reactions |
| 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 |
| Evaluation of symptom reduction of sputum and cough | after 6 months | — |
Countries
Germany
Outcome results
None listed