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.
ovartis Healthcare Private Limited0 个研究点目标入组 336 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 336
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •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
研究者
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