Asthma Clinical Trial
Official title:
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:
1. Rollover patients who had completed any of the four Phase 3 pivotal efficacy studies
with QAW039 (QAW039A2307, QAW039A2314, QAW039A2316, or QAW039A2317, hereafter referred
to as Studies A2307, A2314, A2316, and A2317), thus providing data for a longer duration
of exposure, and
2. New patients who had not previously participated in a study of QAW039, permitting an
increase in the number of patients with long-term exposure to QAW039.
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. ;
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