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
概览
- 阶段
- 3 期
- 干预措施
- QAW039
- 疾病 / 适应症
- Asthma
- 发起方
- Novartis Pharmaceuticals
- 入组人数
- 675
- 试验地点
- 110
- 主要终点
- Change From Baseline in Pre-dose FEV1 at Week 12
- 状态
- 已完成
- 最后更新
- 3个月前
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.
研究者
入排标准
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
Placebo
Placebo once daily
干预措施: Placebo
结局指标
主要结局
Change From Baseline in Pre-dose FEV1 at Week 12
时间窗: 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 Daytime Asthma Symptom Score(12 weeks)
- Change From Baseline in Daily Use of SABA(12 weeks)
- Change From Baseline in Asthma Quality of Life (AQLQ+12) Score(Week 12)