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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01285167
Recruitment Status : Completed
First Posted : January 27, 2011
Last Update Posted : October 31, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Drug: Daxas

Study Type : Observational
Actual Enrollment : 3645 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Daxas for COPD Therapy (DACOTA)
Study Start Date : August 2010
Primary Completion Date : February 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
Drug Information available for: Roflumilast
U.S. FDA Resources

Group/Cohort Intervention/treatment
DACOTA Drug: Daxas
500 microgram, oral, once daily as add-on therapy to existing therapy

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients diagnosed with severe COPD.

Main Inclusion Criteria:

  • severe COPD

Main Exclusion Criteria:

  • Child pugh (classified B and C)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01285167

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Sponsors and Collaborators
Study Director: AstraZeneca AstraZeneca AstraZeneca

Responsible Party: AstraZeneca Identifier: NCT01285167     History of Changes
Other Study ID Numbers: RO-2455-401-DE
U1111-1136-8784 ( Other Identifier: WHO )
First Posted: January 27, 2011    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: September 2016

Keywords provided by AstraZeneca:
Quality of life
lung function
severe COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases