A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 704
- 试验地点
- 142
- 主要终点
- Change From Baseline in Pre-dose FEV1
研究概览
简要总结
A randomized, multicenter, double-blind, placebo- controlled parallel-group study to determine the efficacy and safety of QAW039, compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1 second (FEV1) at the end of 12 weeks of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months.
- •Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose ICS plus long- acting beta agonist (LABA), or low dose ICS plus leukotriene receptor antagonist (LTRA), or medium dose ICS plus LABA for at least 3 months prior to Visit 1 and the doses have been stable for at least 4 weeks prior to Visit
- •FEV1 of ≤85% for patients aged ≥18 years. FEV1 of ≤90% for patients aged 12 to <18 years.
- •Daytime asthma symptom score (0 to 6 scale) of ≥1 per day during 4 of the last 7 days of the placebo run- in period.
- •Total daily SABA use ≥1 puff per day during 4 of the last 7 days of the placebo run-in period.
- •Demonstrated reversible airway obstruction.
- •Asthma control questionnaire (ACQ) score ≥ 1.5.
排除标准
- •Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.
- •A resting QTcF (Fridericia) ≥450 msec (male) or
- •≥460 msec (female).
- •Pregnant or nursing (lactating) women.
- •Serious co-morbidities.
- •Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
QAW039
QAW039 once daily
干预措施: QAW039 (Drug)
Placebo
Placebo once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Pre-dose FEV1
时间窗: Baseline and Week 12
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.
次要结局
- Change From Baseline in Number of Puffs of SABA Taken Per Day(Baseline (daily mean for up to three weeks prior to baseline visit) and Week 12 (daily mean post baseline up to Week 12))
- Change From Baseline in Daytime Asthma Symptom Score(Baseline and Week 12)
- Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ+12) Score(Baseline and Week 12)