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

Boehringer Ingelheim1,296 enrolled

Overview

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.

Study Design:

Study Type

OBSERVATIONAL

Enrollment

1,296

Conditions

Chronic Obstructive Pulmonary Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

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

Secondary Outcomes

The secondary endpoint was the change in the standardised PF-10 score within 6 weeks of treatment with Spiriva® 18 Microgram

Time frame: 6 weeks

Data from ClinicalTrials.gov

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