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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.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: January 21, 2011
Last updated: October 27, 2016
Last verified: September 2016

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


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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01285167

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

Responsible Party: AstraZeneca Identifier: NCT01285167     History of Changes
Other Study ID Numbers: RO-2455-401-DE
U1111-1136-8784 ( Other Identifier: WHO )
Study First Received: January 21, 2011
Last Updated: October 27, 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 processed this record on August 18, 2017