A Phase II Multinational, Multicentre, Double-blind, Randomised, Active-controlled, 3-way Cross-over Study to Evaluate the Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a Versus CHF5993 pMDI 100/6/12.5 µg HFA-134a in Subjects With Mild to Moderate Asthma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 780
- 试验地点
- 167
- 主要终点
- Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from time zero to 4 hours (AUC0-4h) on Day 1
研究概览
简要总结
This study will compare an asthma inhaler that uses a new climate friendly alternative propellant to an asthma inhaler with an existing propellant. We want to make sure both versions of the inhaler work the same way for people with mild to moderate asthma.
详细描述
This global study aims to compare whether the investigational inhaler with the new HFA-152a propellant is as safe, effective and well tolerated in patients with asthma as the inhalers that use the existing HFA-134a propellant. HFA-152a is a propellant gas that is designed to have a lower global warming potential and to be more climate friendly. The study will be conducted in Europe, Latin America, Ukraine, South Africa and United Kingdom. It is planned to randomize 468 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults (18 ≤ age ≤ 75 years) with a diagnosis of Asthma for at least 6 months prior to screening and with diagnosis before the age of 50 years;
- •Non-smokers, ex-smokers;
- •Body mass index: within the range of 18.0 to 35.0 kg/m2 inclusive;
- •Stable asthma therapy: a stable maintenance treatment for at least 4 weeks prior to screening with:
- •low or medium doses of ICS (Inhaled Corticosteroids) alone; or
- •low or medium doses of ICS + LABA (Long-acting β2-agonist) (fixed or free combination).
- •Controlled or partly controlled based on an Asthma Control Questionnaire - 7 Items (ACQ-7) score <1.5 at screening and at randomisation.
- •Pre-BD (Bronchodilator) FEV1 >40% and <90% of the predicted normal value, after appropriate wash out from BDs, at the Screening Visit (V1).
- •A demonstrated increase in either FEV1 or forced vital capacity of >12% and >200 mL from baseline within 30 minutes (min) after inhalation of 400 µg salbutamol (i.e. albuterol) pMDI at the Screening Visit (V1).
排除标准
- •History of near fatal asthma or hospitalisation for asthma in intensive care unit, inpatient setting or emergency room access for asthma in the previous 6 months prior to screening, which in the judgement of the Investigator may place the subjects at undue risk;
- •Recent asthma exacerbation requiring systemic corticosteroids (SCSs), or emergency room admission or hospitalisation within 3 months prior to screening and/or during the run-in period ;
- •Non-persistent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine;
- •Asthma subjects currently treated with any of the following :
- •High dose ICS;
- •Long-acting muscarinic antagonist (LAMA);
- •Systemic, depot or slow-release corticosteroids within 12 weeks prior to screening;
- •Any other asthma treatments (e.g. cromolyn sodium, nedocromil sodium, leukotriene modifiers) within 4 weeks prior to screening;
- •Any biologic therapy (e.g. omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab) within 6 months prior to screening;
- •Respiratory disorders other than asthma
- •Lung resection;
- •Lower respiratory tract infection;
- •Lung cancer and history of lung cancer;
- •Subjects with active cancer or a history of cancer (other than lungs) ;
- •Patients who have clinically significant cardiovascular condition;
- •Run-in compliance: e-Diary completion <75% and run-in treatment compliance <75% at randomisation;
研究组 & 干预措施
Test Treatment: CHF5993 pMDI (Pressurised Metered Dose Inhaler) with HFA-152a
BDP (Beclometasone Dipropionate)/FF (Formoterol Fumarate)/GB (Glycopyrronium Bromide) 100/6/12.5 µg
干预措施: CHF5993 pMDI with HFA-152a (Drug)
Reference Treatment 1: CHF5993 pMDI with HFA-134a
BDP/FF/GB 100/6/12.5 µg
干预措施: CHF5993 pMDI with HFA-134a (Drug)
Reference Treatment 2: CHF718 pMDI with HFA-134a
BDP 100 µg
干预措施: CHF718 pMDI with HFA-134a (Drug)
结局指标
主要结局
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from time zero to 4 hours (AUC0-4h) on Day 1
时间窗: Day 1
Change from baseline in pre-dose FEV1 on Day 28
时间窗: Day 28
次要结局
未报告次要终点