Quality of Life in Daxas-treated Patients Older Than 18 Years With Severe Chronic Obstructive Pulmonary Disease (COPD) (DACOTA)

Daxas for COPD Therapy (DACOTA)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01285167

Acronym

DACOTA

Enrollment

3645

Registered

2011-01-27

Start date

2010-08-31

Completion date

2012-02-29

Last updated

2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, Quality of life, lung function, spirometry, roflumilast, Daxas, severe COPD

Brief summary

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.

Interventions

DRUGDaxas

500 microgram, oral, once daily as add-on therapy to existing therapy

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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
Pre-/post comparison of spirometry data	after 6 months	—
Evaluation of tolerability	after 6 months	assessment of adverse drug reactions
Evaluation of symptom reduction of sputum and cough	after 6 months	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026