A 2-treatment Period, Randomized, Placebo-controlled, Multicenter Parallel-group Study to Assess the Safety of QAW039 When Added to Existing Asthma Therapy in GINA Steps 3, 4 and 5 Patients With Uncontrolled Asthma.
A 2-treatment Period, Randomized, Placebo-controlled, Multicenter Parallel-group Study to Assess the Safety of QAW039 When Added to Existing Asthma Therapy in GINA Steps 3, 4 and 5 Patients With Uncontrolled Asthma.
This study was a 2-treatment period, randomized, multicenter parallel-group study. The overall purpose of this study was to provide long- term safety data for fevipiprant (QAW039) (Dose 1 and Dose 2), compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with moderate-to- severe asthma.
The purpose of this study was to provide long-term safety data for QAW039 150 mg once daily and 450 mg once daily, compared with placebo, when added to GINA steps 3, 4, and 5 standard-of-care asthma therapy (GINA 2020) in adult and adolescent (≥12 years) patients with moderate-to-severe asthma. The study included 2 cohorts of patients:
By including these 2 categories of patients, the total number of patients treated with QAW039 as well as the duration of exposure to QAW039 treatment was substantially increased, supporting evaluation of the safety profile of QAW039.
The study comprised 2-treatment period. Treatment Period 1 was a 52-week, double-blind treatment period in which QAW039 450 mg or 150 mg or placebo was added to standard-of-care asthma therapy according to GINA guidelines. Treatment Period 2 was an optional 104-week, single-blind treatment period in which patients received QAW039 450 mg or 150 mg or placebo added to standard-of-care asthma therapy according to GINA guidelines.
Inclusion Criteria:
Patients completing a prior Phase 3 study of QAW039:
Patients who have not previously participated in a study of QAW039:
Exclusion Criteria:
Patients completing a prior phase 3 study of QAW039:
Patients who have not previously participated in a study of QAW039:
CABA, Buenos Aires C1056ABJ, Argentina
CABA, Buenos Aires C1122AAK, Argentina
CABA, Buenos Aires C1425BEN, Argentina
CABA, Buenos Aires C1426ABP, Argentina
Xian, Shanxi 710061, China
Cottbus, Saxony 03050, Germany
Gautemala City, Gautemala 01010, Guatemala
Naka-gun, Ibaraki 319-1113, Japan
Chuo Ku, Tokyo 104-0031, Japan
Chuo Ku, Tokyo 104-8560, Japan
Chuo-ku, Tokyo 103-0003, Japan
Chuo-ku, Tokyo 103-0028, Japan
Itabashi-ku, Tokyo 173-8610, Japan
Setagaya-Ku, Tokyo 157-0072, Japan
Setagaya-ku, Tokyo 157006, Japan
Shinagawa-ku, Tokyo 142-8666, Japan
Shinjuku Ku, Tokyo 162 8655, Japan
Shinjuku-ku, Tokyo 169-0073, Japan
Toshima Ku, Tokyo 170 0003, Japan
El Chouf, LBN 1503201002, Lebanon
Guadalajara Jalisco, Jalisco 44220, Mexico
Yenisehir/Izmir, 35110, Turkey (Türkiye)
East Yorkshire, HU16 5JQ, United Kingdom