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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00540163
Recruitment Status : Completed
First Posted : October 5, 2007
Last Update Posted : November 28, 2013
Information provided by:
Boehringer Ingelheim

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.

Condition or disease
Chronic Obstructive Pulmonary Disease

Detailed Description:
Study Design:

Study Type : Observational
Actual Enrollment : 1296 participants
Time Perspective: Prospective
Official Title: 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).
Study Start Date : April 2007
Actual Primary Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients of office-based pulmonology practices

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00540163

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Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim Identifier: NCT00540163     History of Changes
Other Study ID Numbers: 205.402
First Posted: October 5, 2007    Key Record Dates
Last Update Posted: November 28, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action