Quality of Life in Daxas-treated Patients Older Than 18 Years With Severe Chronic Obstructive Pulmonary Disease (COPD) (DACOTA)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: Daxas |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Daxas for COPD Therapy (DACOTA) |
- 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
- Pre-/post comparison of spirometry data [ Time Frame: after 6 months ] [ Designated as safety issue: No ]
- Evaluation of tolerability [ Time Frame: after 6 months ] [ Designated as safety issue: Yes ]assessment of adverse drug reactions
- Evaluation of symptom reduction of sputum and cough [ Time Frame: after 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 3645 |
| Study Start Date: | August 2010 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| DACOTA |
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 605 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: | NCT01285167 History of Changes |
| Other Study ID Numbers: | RO-2455-401-DE, U1111-1136-8784 |
| 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 lung function spirometry |
roflumilast Daxas severe COPD |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013