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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01285167
First Posted: January 27, 2011
Last Update Posted: October 31, 2016
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.
Information provided by (Responsible Party):
AstraZeneca
  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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • Effectiveness during treatment [ Time Frame: after 6 months ]
    Evaluation of treatment success by a health status patient questionnaire

  • Pre-/post comparison of spirometry data [ Time Frame: after 6 months ]
  • Evaluation of tolerability [ Time Frame: after 6 months ]
    assessment of adverse drug reactions

  • Evaluation of symptom reduction of sputum and cough [ Time Frame: after 6 months ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
Criteria

Main Inclusion Criteria:

  • severe COPD

Main Exclusion Criteria:

  • Child pugh (classified B and C)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01285167


  Show 605 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca AstraZeneca AstraZeneca
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01285167     History of Changes
Other Study ID Numbers: RO-2455-401-DE
U1111-1136-8784 ( Other Identifier: WHO )
First Submitted: January 21, 2011
First Posted: January 27, 2011
Last Update Posted: October 31, 2016
Last Verified: September 2016

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

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