A Single Dose, Randomised, Double Blind, Double Dummy, Placebo Controlled, 3-way Crossover Clinical Study, Comparing the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 100/6 µg NEXThaler® Versus CHF1535 100/6 µg pMDI in Asthmatic Patients.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 3
- 主要终点
- Change in FEV1 5-min post-dose
研究概览
简要总结
The clinical trial is designed to evaluate the non-inferiority of CHF1535 100/6 µg NEXThaler versus CHF1535 100/6 µg pMDI on the onset of relief from methacholine-induced bronchospasm, in terms of pulmonary function (i.e. change in Forced Expiratory Volume in the 1st second, FEV1, from baseline to 5 min after study drug intake) in asthmatic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent form obtained
- •Minimum required Peak Inspiratory Flow (PIF) to activate NEXThaler
- •Pre-bronchodilator FEV1 of at least 65%
- •Positive response to methacholine challenge test
- •Previous treatment with low-medium doses of Inhaled Corticosteroids (ICS) or ICS/Long-acting beta2-agonist (LABA) as per Global Initiative for Asthma (GINA) 2016 guidelines
- •For females: non-pregnant, non-lactacting and using highly effective contraceptive methods.
排除标准
- •Clinically relevant and uncontrolled concomitant diseases
- •Abnormal clinically relevant ECG
- •Presence of aortic aneurism
- •Uncontrolled hypertension
- •Intake of non-permitted concomitant medications
- •Participation in another clinical trials in the previous 8 weeks
- •Seasonal variation in asthma
- •Recent occurrence of asthma exacerbations
- •Hypersensitivity to any product used in the trial, including excipients
- •Heavy caffeine drinkers
- •History of alcohol/drug abuse
研究组 & 干预措施
CHF1535 NEXThaler
CHF1535 100/6 NEXThaler (Beclometasone dipropionate 100 µg + formoterol fumarate 6 µg)
干预措施: CHF1535 NEXThaler (Drug)
CHF1535 pMDI
CHF1535 100/6 pMDI (Beclometasone dipropionate 100 µg + formoterol fumarate 6 µg)
干预措施: CHF1535 pMDI (Drug)
Placebo
Double dummy study: placebo is for both CHF1535 pMDI and CHF1535 NEXThaler
干预措施: Placebo (Drug)
结局指标
主要结局
Change in FEV1 5-min post-dose
时间窗: 5 min post-dose
Change in FEV1 from baseline (baseline is the post-diluent value, before methacholine challenge test)
次要结局
- Change in FEV1 other time points(Up to 30 min post-dose)
- FEV1 AUC0-10min(From dosing to 10 min post-dose)
- Change in Borg scale(Up to 30 min post-dose)
- Time to recovery in FEV1(From dosing to 30 min post-dose)
- Time to recovery in Borg scale(Up to 30 min post-dose)