Assessment of Physical Activity (PF10 Sub Domain of SF-36 Activity Score) and Tolerability in COPD Patients During Treatment With Spiriva® Respimat®

Boehringer Ingelheim9 sites in 1 country1,280 target enrollmentJune 2008

ConditionsPulmonary Disease, Chronic Obstructive

Overview

Phase: N/A
Intervention: Not specified
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Enrollment: 1280
Locations: 9
Primary Endpoint: Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2008

End Date

January 2009

Last Updated

12 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Eligibility 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.

Outcomes

Primary Outcomes

Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks

Time Frame: Baseline and after 6 weeks of treatment

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 Outcomes

Change From Baseline in the PF-10 Score After 6 Weeks(Baseline and after 6 weeks of treatment)
Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety(Baseline and after 6 weeks of treatment)
Patients' Satisfaction After 6 Weeks of Treatment(6 weeks)