CTRI/2014/07/004743已完成2 期
A Double-blind, Placebo-controlled, Study Examining the Effect of Orally Administered QAW039 (450 mg QD) on FEV1 and ACQ in Non-atopic, Asthmatic Patients With a Baseline, Pre-bronchodilator FEV1 of 40-80% Predicted, Inadequately Controlled With Low Dose ICS Therapy.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 336
- 试验地点
- 9
- 主要终点
- Change in trough FEV1 from baseline to 12 weeks of post-baseline treatment in non-atopic asthmatic patients.
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study
to determine whether, in patients with persistent, moderate-to-severe, non-atopic (skin prick test- and specific IgE-negative) asthma inadequately controlled by inhaled corticosteroid (ICS) therapy (100 μg fluticasone BID), 12-weeks treatment with QAW039 at a dose of 450 mg QD (compared to placebo) improves FEV1 and symptom control as measured by the ACQ.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Written informed consent must be obtained before any assessment is performed •Patients with a diagnosis of persistent asthma (according to Global Initiative for Asthma 2011) for a period of at least 6 months prior to screening •Patients with a pre-bronchodilator Forced Expiratory Volume In One Second (FEV1) value of 40% to 80% of individual predicted value at screening and prior to treatment •An Asthma Control Questionnaire score ≥ 1.5 prior to treatment •Demonstration of reversible airway obstruction.
排除标准
- •â€¢Pregnant or nursing (lactating) women •Acute illness other than asthma at the start of the study •Patients with clinically significant laboratory abnormalities at screening •Patients with clinically significant condition which may compromise subject safety or interfere with study evaluation •Use of other investigational drugs at the time of enrollment.
结局指标
主要结局
Change in trough FEV1 from baseline to 12 weeks of post-baseline treatment in non-atopic asthmatic patients.
时间窗: Baseline and Week 12
To assess the efficacy of QAW039 by Lung Function Assessed by trough Forced Expiratory Volume for 1 Second (FEV1) in non-atopic asthmatics
时间窗: Baseline and Week 12
次要结局
- To assess the change in asthma control as measured by the asthma control questionnaire (ACQ) from baseline to week 12.(Baseline to Week 12)
研究者
研究点 (9)
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