Observational Non-Interventional Study With Spiriva Respimat in COPD Patients

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00699699
First received: June 17, 2008
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

This observational non-interventional study is designed to demonstrate the improvement of physical function in COPD patients on treatment with Spiriva Respimat and allows adverse events to be recorded and evaluated.


Condition
Pulmonary Disease, Chronic Obstructive

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Assessment of Physical Activity (PF10 Sub Domain of SF-36 Activity Score) and Tolerability in COPD Patients During Treatment With Spiriva® Respimat®

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks [ Time Frame: Baseline and after 6 weeks of treatment ] [ Designated as safety issue: No ]
    Main efficacy measure was therapeutic success rate defined as an improvement from baseline after 6 weeks by at least 10 score points in the PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)


Secondary Outcome Measures:
  • Change From Baseline in the PF-10 Score After 6 Weeks [ Time Frame: Baseline and after 6 weeks of treatment ] [ Designated as safety issue: No ]
    Numerical changes in physical functioning (PF-10) after 6 weeks of treatment. PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)

  • Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety [ Time Frame: Baseline and after 6 weeks of treatment ] [ Designated as safety issue: No ]
    Changes in Physician's Global Evaluation in physical functioning from baseline after 6 weeks of treatment (measured as 8 point scale with classifications "poor" (1, 2), "satisfactory" (3, 4), "good" (5, 6), and "excellent" (7, 8))

  • Patients' Satisfaction After 6 Weeks of Treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Patients' satisfaction with the Spiriva® Respimat® device after 6 weeks of treatment ("very satisfied", "satisfied", "rather satisfied", "neither satisfied nor "unsatisfied", "rather unsatisfied", "unsatisfied", and "very unsatisfied")


Enrollment: 1280
Study Start Date: June 2008
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
  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 who require treatment with longacting anticholinergic

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. Spiriva® Respimat® is contraindicated in patients with hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699699

  Show 188 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00699699     History of Changes
Other Study ID Numbers: 205.426
Study First Received: June 17, 2008
Results First Received: January 13, 2010
Last Updated: March 12, 2014
Health Authority: Germany: BfArM (Bundesinstitut für Arzneimittel und Medizinalprodukte)

Keywords provided by Boehringer Ingelheim:
Chronic Obstructive Pulmonary Disease (COPD)

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

ClinicalTrials.gov processed this record on April 14, 2014