Status:
COMPLETED
Safety and Effectiveness of Spiriva in COPD (Chronic Obstructive Pulmonary Disease) Patients Under the Real Condition of Usual Practice
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-80 years
Brief Summary
The purpose of this study is to monitor the change in the health status of severe COPD patients after the initiation of Tiotropium therapy. This will be assessed by the physician's global evaluation o...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with confirmed diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD; updated 2005).
- Patients who are assessed to benefit from the intake of long-acting anticholinergics as a monotherapy or as add-on medication.
- Tiotropium bromide naïve patients.
- Patients with indication for tiotropium bromide according to Taiwanese Spiriva® label.
- Exclusion criteria:
- Patients with contraindications to tiotropium bromide use (as per the Spiriva® package insert).
- Known hypersensitivity to the active ingredient or to any of the excipients of Spiriva®.
Exclusion
Key Trial Info
Start Date :
December 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
2031 Patients enrolled
Trial Details
Trial ID
NCT00624377
Start Date
December 1 2007
Last Update
March 28 2014
Active Locations (16)
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1
Boehringer Ingelheim Investigational Site
Chan Wha, Taiwan
2
Boehringer Ingelheim Investigational Site
Chiayi City, Taiwan
3
Boehringer Ingelheim Investigational Site
Hwa Lian, Taiwan
4
Boehringer Ingelheim Investigational Site 1
Kaohsiung City, Taiwan