Regulatory Requisite Post Marketing Surveillance to Assess the Safety and Efficacy of Spiriva® HandiHaler® (Tiotropium Bromide Inhalation Powder 18mcg, q.d.) in Korean COPD Patients: A 30-Day, Open Label, Non-interventional Study
Regulatory Requisite Post Marketing Surveillance to Assess the Safety and Efficacy of Spiriva® HandiHaler® (Tiotropium Bromide Inhalation Powder 18mcg, q.d.) in Korean COPD Patients: A 30-Day, Open Label, Non-interventional Study
This is a descriptive observational open non-comparative study of the safety and efficacy of tiotropium inhalation capsule given at 18mcg 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 18mcg 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 Design:
Inclusion Criteria:
Older than 40 years old Diagnosed as COPD No Previous Spiriva administration No Contraindication for Spiriva according to the product label
Exclusion Criteria:
patients with history of hypersensitivity to atropine and its derivatives (e.g. ipratropium oxitropium or any component of this product).
Chugnam, South Korea
Chugnam, South Korea
Chugnam, South Korea
Gangwondo, South Korea
Gangwondo, South Korea
Gangwondo, South Korea
Gangwondo, South Korea
Gyeonggido, South Korea
Gyeonggido, South Korea
Gyeonggido, South Korea
Gyeonggido, South Korea
Gyeonggido, South Korea
Gyeonggido, South Korea
Gyeonggido, South Korea
Gyeonggido, South Korea
Gyeonggido, South Korea
Gyeongnam, South Korea
Gyeongnam, South Korea
Jeonbuk, South Korea
Jeonbuk, South Korea
Jeonbuk, South Korea
Jeonnam, South Korea
Jeonnam, South Korea
Jeonnam, South Korea
Jeonnam, South Korea
Jeonnam, South Korea
Jeonnam, South Korea
Jeonnam, South Korea