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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00699699 |
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 |
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Pulmonary Disease, Chronic Obstructive |
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® |
Study Start Date: | June 2008 |
Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
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) |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Chronic Disease Tiotropium Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases |
Lung Diseases Chronic Disease Pulmonary Disease, Chronic Obstructive |