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Assessment of Chronic Obstructive Pulmonary Disease (COPD) Therapy From the Physicians Perspective Using Tiotropium as an Example

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01036763
First received: December 18, 2009
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

Documentation of successful therapy with tiotropium (Spiriva Respimat; Spiriva (tiotropium 18 mcg capsules)) in COPD patients requiring long-acting bronchodilators: description of the most important outcome parameters according to the physicians assessment to determine the success of therapy. Such data are not yet available.

Also collection of physicians assessments and patients assessments of efficacy and tolerability of Spiriva Respimat, Spiriva (tiotropium 18 mcg capsules).


Condition
Pulmonary Disease, Chronic Obstructive

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Assessment of COPD Therapy From the Physicians Perspective Using Tiotropium as an Example

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Success of Treatment With Tiotropium According to Physician's Assessment [ Time Frame: 6 - 12 weeks ] [ Designated as safety issue: No ]
    Evaluation of important outcome parameters (pulmonary function, dyspnoe, health-related quality of life, exercise capacity, prevention of exacerbations) which were used for the physician´s decision to assess the treatment as successful

  • Assessment of Efficacy According to Physician [ Time Frame: 6 - 12 weeks ] [ Designated as safety issue: No ]
    Physician's assessment of efficacy within categories (positive/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined

  • Assessment of Tolerability According to Physician [ Time Frame: 6 - 12 weeks ] [ Designated as safety issue: No ]
    Physician's assessment of tolerability (positve/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined

  • Assessment of Efficacy According to Patient [ Time Frame: 6 - 12 weeks ] [ Designated as safety issue: No ]
    patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)

  • Assessment of Tolerability According to Patient [ Time Frame: 6 - 12 weeks ] [ Designated as safety issue: No ]
    Patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)


Secondary Outcome Measures:
  • Physician's Global Evaluation at Visit 1 [ Time Frame: 0 weeks ] [ Designated as safety issue: No ]
    Physician's global evaluation (PGE) of the patients' general condition at Visit 1 evaluated on an 8-point scale with the scores "Poor (1, 2)", "Satisfactory (3, 4)", "Good (5, 6)" and "Excellent (7, 8)" prior to treatment with Spiriva.

  • Physician's Global Evaluation at Visit 2 [ Time Frame: after 6 - 12 weeks ] [ Designated as safety issue: No ]
    Physician's global evaluation (PGE) of the patients' general condition at Visit 2 evaluated on an 8-point scale after approximately 6-12 weeks of treatment with Spiriva.


Study Start Date: January 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Study Design:

observational

  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

Criteria

Inclusion criteria COPD patients requiring long-acting bronchodilators according to approved Summary of Product Characteristics (SPC) and guidelines

Exclusion criteria Patients cannot be recruited if any of the general or specific contraindications listed in the Patient information leaflet or the Summary of Product Characteristics applies.

  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: NCT01036763

  Show 352 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Pfizer
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
Publications:
Rau-Berger H, Kroker A, Mitfessel H, Schmidt H, Glaab T Assessment of COPD-therapy with tiotropium by the treating pneumologist. 53rd Cong of the German Respiratory Society, Nuremberg, 29 Mar - 1 Apr 2012 (Poster), (2012)

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01036763     History of Changes
Other Study ID Numbers: 205.455
Study First Received: December 18, 2009
Results First Received: February 15, 2012
Last Updated: February 27, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on November 20, 2014