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
ClinicalTrials.gov Identifier:
NCT00540163
First received: September 21, 2007
Last updated: November 27, 2013
Last verified: October 2013
  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: 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).

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 177 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
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: November 27, 2013
Health Authority: Germany: BfArM (Bundesinstitut für Arzneimittel und Medizinalprodukte)

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

ClinicalTrials.gov processed this record on October 02, 2014