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

Observational Non-Interventional Study With Spiriva Respimat in Chronic Obstructive Pulmonary Disease (COPD) Patients

This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, September 2008

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)

ChemIDplus related topics:

Tiotropium Tiotropium bromide

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 ]

Estimated Enrollment:	2000
Study Start Date:	June 2008
Estimated Primary Completion Date:	December 2008 (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

Contacts


Contact: Boehringer Ingelheim Study Coordinator		clintriage.rdg@boehringer-ingelheim.com

Show 119 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators


Study Chair:	Boehringer Ingelheim	Boehringer Ingelheim Pharmaceuticals

More Information

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	205.426
First Received:	June 17, 2008
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00699699
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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:

Disease Attributes

Pathologic Processes

ClinicalTrials.gov processed this record on October 10, 2008