A 24-week Multi-center, Double-blind, Placebo Controlled Dose-range Finding Study to Investigate the Efficacy and Safety of Oral QBW251 in COPD Patients on Triple Inhaled Therapy (LABA / LAMA / ICS)
A 24-week Multi-center, Double-blind, Placebo Controlled Dose-range Finding Study to Investigate the Efficacy and Safety of Oral QBW251 in COPD Patients on Triple Inhaled Therapy (LABA / LAMA / ICS)
This clinical study was designed to support the dose selection for future studies by evaluating efficacy and safety of different QBW251 doses in Chronic obstructive pulmonary disease (COPD) patients with chronic bronchitis and a history of exacerbations, compared to placebo, when added to a triple inhaled therapy of LABA, LAMA and ICS.
This study used a 6 treatment arm, parallel-group, randomized, double-blind study design. 974 male and female COPD patients were randomized into the trial. The study consisted of four distinct study periods:
Inclusion Criteria:
Exclusion Criteria:
Ciudad Autonoma de Bs As, C1425FVH, Argentina
Ostrava Poruba, Czech Republic 708 68, Czechia
Heraklion Crete, Greece 711 10, Greece
Pokfulam, Hong Kong, Hong Kong
Naka-gun, Ibaraki 319-1113, Japan
Chuo Ku, Tokyo 104-0031, Japan
Chuo-ku, Tokyo 103-0003, Japan
Chuo-ku, Tokyo 103-0028, Japan
Setagaya-Ku, Tokyo 157-0072, Japan
Setagaya-ku, Tokyo 158-8531, Japan
Shinagawa, Tokyo 140-8522, Japan
Toshima Ku, Tokyo 170 0003, Japan