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
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

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

ClinicalTrials.gov processed this record on April 17, 2014