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OpenTrials
Completed

NCT Number: NCT01285167

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nycomed Deutschland GmbH, Ahlen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • severe COPD

Main Exclusion Criteria:

  • Child pugh (classified B and C)

Treatment and study plan

Daxas

Drug

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

Primary outcomes

  1. Pre-/post comparison of the COPD status based on patients health status

    Time frame: after 6 months

    Evaluation of treatment success by a COPD-specific patient questionnaire

Secondary outcomes

  1. Effectiveness during treatment

    Time frame: after 6 months

    Evaluation of treatment success by a health status patient questionnaire

  2. Pre-/post comparison of spirometry data

    Time frame: after 6 months

  3. Evaluation of tolerability

    Time frame: after 6 months

    assessment of adverse drug reactions

  4. Evaluation of symptom reduction of sputum and cough

    Time frame: after 6 months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Daxas for COPD Therapy (DACOTA)

Acronym: DACOTA

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 27, 2011
Registry last updated
Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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