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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):
AstraZeneca

Tracking Information
First Submitted Date January 21, 2011
First Posted Date January 27, 2011
Last Update Posted Date October 28, 2016
Study Start Date August 2010
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 26, 2011)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01285180 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 26, 2011)
  • Effectiveness during treatment [ Time Frame: after 6 months ]
    Evaluation of treatment success by a health status patient questionnaire
  • Evaluation of tolerability [ Time Frame: after 6 months ]
    assessment of adverse drug reactions
  • Evaluation of cost-of-illness data [ Time Frame: before treatment ]
    number of consultations, sick leave, hospitalisation, number of and duration of rehab measures
  • Evaluation of sociodemographic data [ Time Frame: before treatment ]
    employment status, disease management programme
  • Evaluation of symptom reduction of sputum and cough [ Time Frame: after 6 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Quality of Life in Daxas-treated Patients Older Than 18 Years With Severe COPD
Official Title Daxas in COPD Therapy
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients diagnosed with severe COPD.
Condition Severe COPD
Intervention Drug: Daxas
500 microgram, oral, once daily as add-on therapy to existing therapy
Study Groups/Cohorts DINO
Intervention: Drug: Daxas
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 7, 2012)
5472
Original Estimated Enrollment
 (submitted: January 26, 2011)
10000
Actual Study Completion Date August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Main Inclusion Criteria:

  • severe COPD

Main Exclusion Criteria:

  • Child pugh (classified B and C)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01285180
Other Study ID Numbers RO-2455-402-DE
U1111-1136-8860 ( Registry Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AstraZeneca
Study Sponsor AstraZeneca
Collaborators Not Provided
Investigators
Study Director: AstraZeneca AstraZeneca AstraZeneca
PRS Account AstraZeneca
Verification Date September 2016