Quality of Life in Daxas-treated Patients Older Than 18 Years With Severe Chronic Obstructive Pulmonary Disease (COPD) (DACOTA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01285167
First received: January 21, 2011
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

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 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

  • Pre-/post comparison of spirometry data [ Time Frame: after 6 months ] [ Designated as safety issue: No ]
  • Evaluation of tolerability [ Time Frame: after 6 months ] [ Designated as safety issue: Yes ]
    assessment of adverse drug reactions

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

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

  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: NCT01285167

  Show 605 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: NCT01285167     History of Changes
Other Study ID Numbers: RO-2455-401-DE, U1111-1136-8784
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
lung function
spirometry
roflumilast
Daxas
severe COPD

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

ClinicalTrials.gov processed this record on October 22, 2014