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Observational Non-interventional Study With Spiriva in Chronic Obstructive Pulmonary Disease Patients With Exercise-induced Dyspnoea

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).

NCT00540163•Boehringer Ingelheim

View on ClinicalTrials.gov

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:

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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.

Locations (177)

Boehringer Ingelheim Investigational Site

Amberg, Germany

Boehringer Ingelheim Investigational Site

Anklam, Germany

Boehringer Ingelheim Investigational Site

Aschau, Germany

Boehringer Ingelheim Investigational Site

Auerbach, Germany

Boehringer Ingelheim Investigational Site

Augsburg, Germany

Boehringer Ingelheim Investigational Site

Backnang, Germany

Boehringer Ingelheim Investigational Site

Bad Doberan, Germany

Boehringer Ingelheim Investigational Site

Bad Lippspringe, Germany

Boehringer Ingelheim Investigational Site

Bad Oeynhausen, Germany

Boehringer Ingelheim Investigational Site

Bad Soden, Germany

Key Dates

Start Date

April 1, 2007

Primary Completion Date

November 1, 2007

Last Updated

November 28, 2013

Enrollment

1,296

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Sponsors

Lead Sponsor

Boehringer Ingelheim

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 28, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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