Quality of Life in Daxas-treated Patients Older Than 18 Years With Severe COPD (DINO)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Severe COPD |
Drug: Daxas |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Daxas in COPD Therapy |
- Pre-/post comparison of the COPD status based on patients health status [ Time Frame: after 6 months ] [ Designated as safety issue: No ]Evaluation of treatment success by a COPD-specific patient questionnaire
- Effectiveness during treatment [ Time Frame: after 6 months ] [ Designated as safety issue: No ]Evaluation of treatment success by a health status patient questionnaire
- Evaluation of tolerability [ Time Frame: after 6 months ] [ Designated as safety issue: Yes ]assessment of adverse drug reactions
- Evaluation of cost-of-illness data [ Time Frame: before treatment ] [ Designated as safety issue: No ]number of consultations, sick leave, hospitalisation, number of and duration of rehab measures
- Evaluation of sociodemographic data [ Time Frame: before treatment ] [ Designated as safety issue: No ]employment status, disease management programme
- Evaluation of symptom reduction of sputum and cough [ Time Frame: after 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 5472 |
| Study Start Date: | August 2010 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| DINO |
Drug: Daxas
500 microgram, oral, once daily as add-on therapy to existing therapy
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
patients diagnosed with severe COPD.
Main Inclusion Criteria:
- severe COPD
Main Exclusion Criteria:
- Child pugh (classified B and C)
Contacts and Locations
Show 2412 Study Locations| Study Director: | PD Thomas D. Bethke, MBA, MD | Nycomed Deutschland GmbH |
More Information
No publications provided
| Responsible Party: | Takeda Global Research & Development Center, Inc. ( Nycomed: A Takeda Company ) |
| ClinicalTrials.gov Identifier: | NCT01285180 History of Changes |
| Other Study ID Numbers: | RO-2455-402-DE, U1111-1136-8860 |
| Study First Received: | January 21, 2011 |
| Last Updated: | November 7, 2012 |
| Health Authority: | Germany: Landesärztekammer Baden-Württemberg |
Keywords provided by Takeda Global Research & Development Center, Inc.:
|
COPD Quality of life sociodemographic data |
cost-of-illness data roflumilast Daxas |
Additional relevant MeSH terms:
|
Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013