A 12-week, Multicenter, Randomized, Double-blind, Parallel-arm, Placebo-controlled Study to Assess the Efficacy and Safety of CSJ117, When Added to Existing Asthma Therapy in Patients ≥ 18 Years of Age With Severe Uncontrolled Asthma.
A 12-week, Multicenter, Randomized, Double-blind, Parallel-arm, Placebo-controlled Study to Assess the Efficacy and Safety of CSJ117, When Added to Existing Asthma Therapy in Patients ≥ 18 Years of Age With Severe Uncontrolled Asthma.
The purpose of this study is to determine the efficacy and safety of multiple CSJ117 doses (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult patients with uncontrolled asthma with respect to change from baseline in FEV1 at the end of 12 weeks of treatment.
This was a randomized, multicenter, multi-national, double-blind, placebo-controlled, parallel-arm study evaluating the effect of 5 dose levels of CSJ117 in adult subjects with inadequately controlled asthma despite medium to high dose inhaled corticosteroid (ICS) plus long-acting beta agonist (LABA).
Subjects were assigned to one of the following six treatment arms/groups in a ratio of 2:1:1:1:2:2:
The study included:
Patients who successfully completed 12 weeks of treatment in this study could be offered participation in the Safety Extension Study CCSJ117A12201E1 (NCT04946318).
Inclusion Criteria:
Exclusion Criteria:
CABA, Buenos Aires C1056ABJ, Argentina
CABA, Buenos Aires C1122AAK, Argentina
CABA, Buenos Aires C1414AIF, Argentina
CABA, Buenos Aires C1425BEN, Argentina
CABA, C1430CAE, Argentina
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 158-0097, Japan
Toshima Ku, Tokyo 170 0003, Japan