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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00540163
First received: September 21, 2007
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
  Purpose

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
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Observational Non-interventional Study to Evaluate Improvement in Physical Function (PF10 Subdomain of SF36) in Chronic Obstructive Pulmonary Disease Patients With Exercise-induced Dyspnoea on Treatment With Spiriva (Capsules Containing 18 µg Tiotropium)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • safety efficacy (PF 10 of SF36 activity score, Physician's Gobal Efficacy) [ Time Frame: 6 weeks ]

Enrollment: 1296
Study Start Date: April 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Study Design:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients of office-based pulmonology practices

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 Boehringer Ingelheim Pharmaceuticals
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00540163     History of Changes
Other Study ID Numbers: 205.402
Study First Received: September 21, 2007
Last Updated: May 18, 2012
Health Authority: Germany: BfArM (Bundesinstitut für Arzneimittel und Medizinalprodukte)

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013