A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Existing Asthma Therapy in Patients With Uncontrolled Severe Asthma.
A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Existing Asthma Therapy in Patients With Uncontrolled Severe Asthma.
This study aimed to determine the efficacy and safety of QAW039 and QAW039 450 mg compared to placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations:
This study used a randomized, multicenter, double-blind, placebo-controlled parallel-group design in which QAW039 (150 mg and 450 mg) or placebo was added to GINA steps 4 and 5 asthma therapy.
The study included:
The follow-up period applied to all patients except those patients who had entered the optional safety study (CQAW039A2315) directly after the Week 52 study visit
Inclusion Criteria:
Exclusion Criteria:
CABA, Buenos Aires C1122AAK, Argentina
CABA, Buenos Aires C1425BEN, Argentina
CABA, Buenos Aires C1426ABP, Argentina
Vancouver BC, British Columbia V6Z 1Y6, Canada
Plzen-Bory, 305 99, Czechia
Cagliari, Sicily 09042, Italy
Naka-gun, Ibaraki 319-1113, Japan
Bunkyo Ku, Tokyo 113-8431, Japan
Chuo Ku, Tokyo 104-0031, Japan
Setagaya-Ku, Tokyo 157-0072, Japan
Shinagawa-ku, Tokyo 142-8666, Japan
Toshima Ku, Tokyo 170 0003, Japan
El Chouf, LBN 1503201002, Lebanon
Guadalajara Jalisco, Jalisco 44220, Mexico
N.Novgorod, 603126, Russia
Tygerberg, Cape Town 7505, South Africa