A Randomised, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5 µg / 5 µg; 5 µg / 5 µg) (Delivered by the Respimat® Inhaler) Compared With the Individual Components (2.5 µg and 5 µg Tiotropium, 5 µg Olodaterol) (Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD). [TOnado TM 1]
A Randomised, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5 µg / 5 µg; 5 µg / 5 µg) (Delivered by the Respimat® Inhaler) Compared With the Individual Components (2.5 µg and 5 µg Tiotropium, 5 µg Olodaterol) (Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD). [TOnado TM 1]
The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components ( tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD).
Inclusion criteria:
Exclusion criteria:
Caba, Argentina
Caba, Argentina
Capital Federal, Argentina
Cuidad Autonoma de Buenos Airess A, Argentina
San Miguel de Tucuma, Argentina
Vaerløse, Denmark
Aoba-ku, Sendai, Miyagi, Japan
Bunkyo-ku, Tokyo, Japan
Chuo-ku, Kumamoto, Kumamoto, Japan
Gifu, Gifu, Japan
Hakata-ku, Fukuoka, Fukuoka, Japan
Himeji, Hyogo, Japan
Ikoma, Nara, Japan
Jonan-ku, Fukuoka, Fukuoka, Japan
Kagoshima, Kagoshima,, Japan
Kagoshima, Kagoshima, Japan
Kamogawa, Chiba, Japan
Kishiwada, Osaka, Japan
Kitakyusyu,Fukuoka, Japan
Koga, Fukuoka, Japan
Komaki, Aichi, Japan
Komaki, Aichi, Japan
Koshi, Kumamoto, Japan
Koto-ku, Tokyo, Japan
Kuki, Saitama, Japan
Kure, Hiroshima, Japan
Kurume, Fukuoka, Japan
Matsumoto, Nagano, Japan
Matsumoto, Nagano, Japan
Matsusaka, Mie, Japan
Morioka, Iwate, Japan
Nagoya, Aichi, Japan
Nagoya, Aichi, Japan
Okinawa, Urasoe, Japan
Okinawa, Urasoe, Japan
Sayama, Osaka, Japan
Sendai, Miyagi, Japan
Seto, Aichi, Japan
Shinagawa, Tokyo, Japan
Takamatsu, Kagawa, Japan
Takamatsu, Kagawa, Japan
Wakayama, Wakayama, Japan
Yokohama, Kanagawa, Japan
Greenlane East Auckland NZ, New Zealand