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 150 mg and QAW039 450 mg, compared with 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:
Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016).
This study used a randomized, multicenter, double-blind, placebo-controlled parallel-group design in which QAW039 150 mg or QA039 450 mg or placebo was added to standard of care, GINA steps 4 and 5 asthma therapy.
The study included:
Inclusion Criteria:
Exclusion Criteria:
CABA, Buenos Aires C1425BEN, Argentina
Ciudad Autonoma de Bs As, C1425FVH, Argentina
Xian, Shanxi 710061, China
Copenhagen NV, 2400, Denmark
HUS, 00029, Finland
OYS, FIN-90029, Finland
Ciudad, Gautemala 01010, Guatemala
Biaystok, Poland 15-430, Poland
Sangiorgiu de Mures, 547530, Romania
East Yorkshire, HU16 5JQ, United Kingdom
Tyne and Wear, NE29 8NH, United Kingdom