Observational Non-Interventional Study With Spiriva Respimat in COPD Patients

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT00699699
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-17
• Study First Posted: 2008-06-18
• Primary Completion: 2009-01
• Results First Submitted: 2010-01-13
• Results First Submitted QC: 2010-02-26
• Results First Posted: 2010-03-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-12
• Last Update Posted: 2014-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1280

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks	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 Outcome Measures

Name	Time	Method
Change From Baseline in the PF-10 Score After 6 Weeks	Baseline and after 6 weeks of treatment	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	Baseline and after 6 weeks of treatment	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	6 weeks	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")

Trial Locations

Locations (9)

Boehringer Ingelheim Investigational Site 6; 🇩🇪 Hamburg, Germany

Boehringer Ingelheim Investigational Site; 🇩🇪 Zirndorf, Germany

Boehringer Ingelheim Investigational Site 2; 🇩🇪 Wilhelmshaven, Germany

Boehringer Ingelheim Investigational Site 4; 🇩🇪 Solingen, Germany

Boehringer Ingelheim Investigational Site 5; 🇩🇪 München, Germany

Boehringer Ingelheim Investigational Site 1; 🇩🇪 Wilhelmshaven, Germany

Boehringer Ingelheim Investigational Site 3; 🇩🇪 Ulm, Germany

Boehringer Ingelheim Investigational Site 7; 🇩🇪 Berlin, Germany

Boehringer Ingelheim Investigational Site 8; 🇩🇪 Berlin, Germany