Observational Non-Interventional Study With Spiriva Respimat in COPD Patients

Boehringer Ingelheim1,280 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,280

Conditions

Pulmonary Disease, Chronic Obstructive

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (188)

Outcomes

Primary Outcomes

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

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)

Time frame: Baseline and after 6 weeks of treatment

Secondary Outcomes

Change From Baseline in the PF-10 Score After 6 Weeks

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)

Time frame: Baseline and after 6 weeks of treatment

Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety

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))

Time frame: Baseline and after 6 weeks of treatment

Patients' Satisfaction After 6 Weeks of Treatment

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")

Time frame: 6 weeks

Data from ClinicalTrials.gov

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Boehringer Ingelheim Investigational Site

Aachen, Germany

Boehringer Ingelheim Investigational Site

Amberg, Germany

Boehringer Ingelheim Investigational Site

Auerbach, Germany

Boehringer Ingelheim Investigational Site 1

Augsburg, Germany

Boehringer Ingelheim Investigational Site 2

Augsburg, Germany

Boehringer Ingelheim Investigational Site 3

Augsburg, Germany

Boehringer Ingelheim Investigational Site

Backnang, Germany

Boehringer Ingelheim Investigational Site

Bad Doberan, Germany

Boehringer Ingelheim Investigational Site

Bad Kötzing, Germany

Boehringer Ingelheim Investigational Site

Bad Lippspringe, Germany

...and 178 more locations