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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01285180
First received: January 21, 2011
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

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 Intervention
Severe COPD
Drug: Daxas

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Daxas in COPD Therapy

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Pre-/post comparison of the COPD status based on patients health status [ Time Frame: after 6 months ] [ Designated as safety issue: No ]
    Evaluation of treatment success by a COPD-specific patient questionnaire


Secondary Outcome Measures:
  • Effectiveness during treatment [ Time Frame: after 6 months ] [ Designated as safety issue: No ]
    Evaluation of treatment success by a health status patient questionnaire

  • Evaluation of tolerability [ Time Frame: after 6 months ] [ Designated as safety issue: Yes ]
    assessment of adverse drug reactions

  • Evaluation of cost-of-illness data [ Time Frame: before treatment ] [ Designated as safety issue: No ]
    number of consultations, sick leave, hospitalisation, number of and duration of rehab measures

  • Evaluation of sociodemographic data [ Time Frame: before treatment ] [ Designated as safety issue: No ]
    employment status, disease management programme

  • Evaluation of symptom reduction of sputum and cough [ Time Frame: after 6 months ] [ Designated as safety issue: No ]

Enrollment: 5472
Study Start Date: August 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
DINO Drug: Daxas
500 microgram, oral, once daily as add-on therapy to existing therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01285180

  Show 2412 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: PD Thomas D. Bethke, MBA, MD Nycomed Deutschland GmbH
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01285180     History of Changes
Other Study ID Numbers: RO-2455-402-DE, U1111-1136-8860
Study First Received: January 21, 2011
Last Updated: November 7, 2012
Health Authority: Germany: Landesärztekammer Baden-Württemberg

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

ClinicalTrials.gov processed this record on October 21, 2014