Status:
COMPLETED
Spiriva® 18µg Once Daily in Chinese COPD Patients of Different Disease Severities
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Brief Summary
The objective of the present Post Marketing Surveillance Study (PMS) study is to evaluate safety and effectiveness of tiotropium bromide (Spiriva®) 18 µg once daily in 5,000 patients with COPD of vary...
Detailed Description
Study Design:
Eligibility Criteria
Inclusion
- Incl. Criteria Patients with clinical diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) according to definition of China COPD guideline.
- Patients over 40 years old
Exclusion
- Patient with history of hypersensitivity to tiotropium bromide, atropine and/or its derivant, i.e. ipratropium, or any component of Spiriva® Patient with known narrow-angle glaucoma
- Patient with known symptomatic prostatic hyperplasia and/or bladder-neck obstruction
- Patient with known moderate to severe renal impairment (i.e.,creatinin clearance\<=50ml/min)
- Pregnant or nursing women
- Patient with any significant disease other than COPD which would exclude him/her from participating in the study
- Patients with any conditions listed in \[special precautions\], \[drug interactions\], and \[contraindication\] of Spiriva® China package insert
- Patients with signed informed consent of any other study
Key Trial Info
Start Date :
May 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
4918 Patients enrolled
Trial Details
Trial ID
NCT00621582
Start Date
May 1 2006
Last Update
October 23 2014
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