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Completed

NCT Number: NCT01285180

Quality of Life in Daxas-treated Patients Older Than 18 Years With Severe COPD

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.

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Key information

Conditions

Severe COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nycomed Deutschland GmbH, Aachen, Germany

Loading trial locations.

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. Evaluation of tolerability

    Time frame: after 6 months

    assessment of adverse drug reactions

  3. Evaluation of cost-of-illness data

    Time frame: before treatment

    number of consultations, sick leave, hospitalisation, number of and duration of rehab measures

  4. Evaluation of sociodemographic data

    Time frame: before treatment

    employment status, disease management programme

  5. 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 in COPD Therapy

Acronym: DINO

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 27, 2011
Registry last updated
Oct 28, 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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