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

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.
ClinicalTrials.gov Identifier: NCT01285180
Recruitment Status : Completed
First Posted : January 27, 2011
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Severe COPD Drug: Daxas

Study Design

Study Type : Observational
Actual Enrollment : 5472 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Daxas in COPD Therapy
Study Start Date : August 2010
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Roflumilast
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

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. 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 ]

Eligibility Criteria

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.
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): NCT01285180


  Show 2412 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca AstraZeneca AstraZeneca
More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01285180     History of Changes
Other Study ID Numbers: RO-2455-402-DE
U1111-1136-8860 ( Registry Identifier: WHO )
First Posted: January 27, 2011    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: September 2016

Keywords provided by AstraZeneca:
COPD
Quality of life
sociodemographic data
cost-of-illness data
roflumilast
Daxas