Improvement in Physical Functioning (SF-36 Activity Score) in COPD Patients With Exercise-induced Dyspnoea on Treatment With Spiriva® 18 Microgram (Capsules Containing 18 μg Tiotropium).

Boehringer Ingelheim1 site in 1 country1,296 target enrollmentApril 2007

ConditionsChronic Obstructive Pulmonary Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Boehringer Ingelheim
Enrollment: 1296
Locations: 1
Primary Endpoint: The primary endpoint was the proportion of patients with an improvement by ≥10 points in the standardised PF-10 score after 6 weeks of treatment with Spiriva® 18 Microgram
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 with exercise-induced dyspnoea on treatment with Spiriva (tiotropium 18 µg capsules) and allows adverse events to be recorded and evaluated.

Detailed Description

Study Design:

Registry

clinicaltrials.gov

Start Date

April 2007

End Date

November 2007

Last Updated

12 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Eligibility Criteria

Inclusion Criteria

•Men or women with COPD and a thoracic gas volume (TGV) of \< 140% at rest, MRC value of 2 or more.

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.
•Tiotropium bromide inhalation powder is contraindicated in patients with a hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to the excipient lactose monohydrate which contains milk protein.

Outcomes

Primary Outcomes

The primary endpoint was the proportion of patients with an improvement by ≥10 points in the standardised PF-10 score after 6 weeks of treatment with Spiriva® 18 Microgram

Time Frame: 6 weeks