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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00620516 |
This is a descriptive observational open non-comparative study of the safety and efficacy of tiotropium inhalation capsule given at 18μg once a day for 30 days among Korean patients with COPD. At Visit 1, patients who are diagnosed as COPD will be prescribed tiotropium inhalation capsule at 18μg once daily (at the same time). Patients' FEV1 will be assessed before start of treatment (Visit 1) and at the end of the 30 day treatment period (Visit 2). Occurrence of adverse events will also be asked from the patient at the end of the 30 day treatment period. Patients will be informed by the attending physicians to immediately report the occurrence of serious adverse events.
Study Type: | Observational |
Official Title: | The Safety and Efficacy of Tiotropium 18ug Inhalation Capsule Using a Handihaler® Among Korean COPD Patients: A 30 Day, Open-Label, Post-Marketing Study |
Estimated Enrollment: | 3000 |
Estimated Study Completion Date: | August 2010 |
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Korea, Republic of | |
Boehringer Ingelheim | |
Seoul, Korea, Republic of | |
Boehringer Ingelheim | |
Gyeonggido, Korea, Republic of | |
Boehringer Ingelheim | |
Daegu, Korea, Republic of | |
Boehringer Ingelheim | |
Busan, Korea, Republic of | |
Boehringer Ingelheim | |
Ulsan, Korea, Republic of | |
Boehringer Ingelheim | |
Incheon, Korea, Republic of | |
Boehringer Ingelheim | |
Daejeon, Korea, Republic of | |
Boehringer Ingelheim | |
Chugnam, Korea, Republic of | |
Boehringer Ingelheim | |
Jeonnam, Korea, Republic of | |
Boehringer Ingelheim | |
Gangwondo, Korea, Republic of | |
Boehringer Ingelheim | |
Jeonbuk, Korea, Republic of |
Study Chair: | Boehringer Ingelheim Study Coordinator | B.I. Korea Ltd. |
Study ID Numbers: | 205.337 |
Study First Received: | February 4, 2008 |
Last Updated: | July 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00620516 |
Health Authority: | Korea: Food and Drug Administration |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Tiotropium Pulmonary Disease, Chronic Obstructive |