Observational Non-Interventional Study With Spiriva in Chronic Obstructive Pulmonary Disease (COPD) Patients With Exercise-Induced Dyspnea - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00540163

Purpose

This observational non-interventional study is designed to demonstrate the improvement of physical function in COPD patients with exercise-induced dyspnea on treatment with Spiriva (tiotropium 18 µg capsules) and allows adverse events to be recorded and evaluated.

Condition	Phase
Chronic Obstructive Pulmonary Disease	Phase IV

MedlinePlus related topics: Breathing Problems COPD (Chronic Obstructive Pulmonary Disease) Exercise and Physical Fitness

Drug Information available for: Tiotropium Tiotropium bromide

U.S. FDA Resources

Study Type:	Observational
Official Title:	Observational Non-Interventional Study to Evaluate Improvement in Physical Function (PF10 Subdomain of SF36) in COPD Patients With Exercise-Induced Dyspnea on Treatment With Spiriva (Capsules Containing 18 µg Tiotropium)

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Evaluation of safety and efficacy (PF 10 of SF36 activity score, Physician's Global Efficacy)

Estimated Enrollment:	2000
Estimated Study Completion Date:	March 2008

Detailed Description:

This observational non-interventional study will demonstrate the efficacy of Spiriva showing improvement of physical function with PF 10 of SF 36 activity score and Physician's Global Efficacy Evaluation Form in COPD patients without or with mild hyperinflation of the lung at rest and dyspnea following gentle exercise in daily practice. Furthermore, adverse events will be recorded and evaluated, thus complementing the data from clinical trials.

Study Hypothesis:

Treatment with Spiriva (tiotropium 18 µg capsules) improves physical function in COPD patients with exercise-induced dyspnea and is well tolerated.

Comparison(s):

N.A.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540163

Show 177 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

B.I. Pharma GmbH & Co. KG

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	205.402
Study First Received:	September 21, 2007
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00540163
Health Authority:	Germany: BfArM (Bundesinstitut fur Arzneimittel und Medizinalprodukte)

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders

Tiotropium
Dyspnea
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 14, 2009