A 24 Week, Randomised, Double Blind, Multicentre, Active Controlled, 2-arm, Parallel Group Trial Comparing Efficacy and Safety of CHF 5993 100/6/12.5 μg HFA-152a pMDI (Fixed Combination of Extrafine Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide) to CHF 1535 100/6 μg HFA-134a pMDI (Fixed Combination of Extrafine Beclometasone Dipropionate Plus Formoterol Fumarate) in Patients With Asthma Uncontrolled on Medium Doses of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 554
- 试验地点
- 1
- 主要终点
- Peak FEV1
研究概览
简要总结
This is a study comparing CHF 5993 pMDI HFA-152a with CHF 1535 pMDI HFA-134a in Chinese patients with asthma uncontrolled on medium doses of ICS+LABA.
详细描述
The study will be conducted at sites in China. The study will be composed of a run-in period with CHF 1535 pMDI HFA-134a (reference product) followed by a 24-week randomised treatment period when CHF 5993 pMDI HFA-152a (test product) or the reference product will be administered. Total study duration is 27 weeks. AEs and SAEs will be monitored from the informed consent signature until the subject's study participation ends, including AEs of particular interest such as cough. Serial spirometry will be performed both for subjects under study treatment as well as for subjects that discontinued the study treatments but continued the study using a different medication
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:
- •Subjects must provide written informed consent prior to any study-related procedures;
- •Subjects must be male or female Chinese aged ≥18 and
- •Subjects must have a documented history of asthma for at least 1 year and asthma must have been diagnosed before the subject's age of 40;
- •Subjects must have uncontrolled asthma, receiving double therapy only on medium doses of ICS in combination with LABA at a stable dose for at least 4 weeks prior to screening;
- •Subjects must have a pre-bronchodilator FEV1 <80% of their predicted normal value, after appropriate wash out from bronchodilators at the screening visit.
- •Subjects must have a positive response to a reversibility test at screening.
- •Subjects must have uncontrolled asthma evidenced by a score at the ACQ-7 ≥1.5 (this criterion must be met at screening and at randomisation).
排除标准
- •Subjects meeting any of the following criteria will be excluded from study enrolment:
- •Subjects who have a history of near fatal asthma or of a past hospitalisation for status asthmaticus or severe asthma exacerbation which, in the judgement of the Investigator, may place the subject at undue risk;
- •Subjects who have undergone hospitalisation, emergency room visit or use of systemic corticosteroids for an asthma exacerbation in the 4 weeks prior to the screening visit or during the run-in period;
- •Subjects with any asthma exacerbation or respiratory tract infection in the 4 weeks prior to the screening visit or during run-in period;
- •Subjects with any change in dose, schedule or formulation of the combination ICS+LABA in the 4 weeks prior to the screening visit;
- •Subjects who have used systemic corticosteroid medication in the 4 weeks prior to screening or slow-release corticosteroids in the 12 weeks prior to screening;
- •Subjects who have a history of a diagnosis of chronic obstructive pulmonary disease (COPD) (according to the Global Initiative for Chronic Obstructive Lung Disease [GOLD] document), cystic fibrosis, bronchiectasis or alpha- 1 antitrypsin deficiency or any other significant lung disease which may interfere with study evaluations;
- •Subjects who are current smokers; ex-smokers with total cumulative exposure ≥10 pack-years; having stopped smoking 1 year or less prior to the screening visit;
- •Subjects who are treated with monoclonal antibodies (e.g., anti-immunoglobulin (Ig)E or anti-IgG antibodies) or biological drugs;
- •Subjects who have received an investigational drug within 2 months or six half-lives (whichever is greater) prior to the screening visit, or have been previously randomised in this study, or are currently participating in another clinical study.
研究组 & 干预措施
CHF 5993 pMDI HFA-152a
Experimental: CHF 5993 pMDI HFA-152a; Fixed combination of beclometasone dipropionate (BDP) 100 μg+formoterol fumarate(FF) 6 μg+glycopyrronium bromide(GB) 12.5 μg, via pressurised metered dose inhaler(pMDI) with HFA-152a propellant.
干预措施: Experimental: Participant Group CHF 5993 pMDI HFA-152a (Drug)
CHF 1535 pMDI HFA-134a
Comparator: CHF 1535 pMDI HFA-134a Fixed combination of BDP 100 μg+FF 6 μg, via pMDI with HFA-134a propellant.
干预措施: Active Comparator: CHF 1535 100/6 μg pMDI HFA-134a (Other)
结局指标
主要结局
Peak FEV1
时间窗: At week 24
FEV1 = forced expiratory volume in the first second
次要结局
- Peak FEV1, FEV1, FEV1 area under curve(AUC)0-3h normalised by time(up to 24 weeks)
- PEF(at week 24)
- ACQ-7 score(up to 24 weeks)
- Average use of rescue medication(at week 24)
- The number of moderate and severe exacerbations(at week 24)
- Time to first moderate or severe exacerbation(at week 24)
- Average daily (morning and evening) asthma symptoms(at week 24)
- Percentage of asthma control days(at week 24)