Observational Non-Interventional Study With Spiriva Respimat in COPD Patients

This study has been completed.

First Received: June 17, 2008 Last Updated: March 5, 2009 History of Changes

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00699699

Purpose

This observational non-interventional study is designed to demonstrate the improvement of physical function in COPD patients on treatment with Spiriva Respimat and allows adverse events to be recorded and evaluated.

Condition
Pulmonary Disease, Chronic Obstructive

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Study Type:	Observational
Official Title:	Assessment of Physical Activity (PF10 Sub Domain of SF-36 Activity Score) and Tolerability in COPD Patients During Treatment With Spiriva® Respimat®

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Evaluation of Improvement in Physical Function (PF10 Subdomain of SF36 questionnaire) [ Time Frame: 6 weeks ]

Secondary Outcome Measures:

Physician's Global Evaluation Form Safety [ Time Frame: 6 weeks ]

Study Start Date:	June 2008
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:

COPD patients who require treatment with longacting anticholinergic

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. Spiriva Respimat is contraindicated in patients with hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699699

Show 188 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	205.426
Study First Received:	June 17, 2008
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00699699 History of Changes
Health Authority:	Germany: BfArM (Bundesinstitut für Arzneimittel und Medizinalprodukte)

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Chronic Disease
Tiotropium
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 07, 2009