NCT06264674已完成3 期
A 12-week Double-blind, Multicentre, Randomised, Active-controlled, 2-arm, Parallel-group Clinical Trial to Evaluate the Safety of CHF5993 pMDI 200/6/12.5 μg HFA-152a, Compared to CHF5993 pMDI 200/6/12.5 μg HFA-134a, in Subjects With Asthma.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 827
- 试验地点
- 231
- 主要终点
- Relative change from pre-dose Forced Expiratory Volume in one second with (FEV1) (Safety Assessment to evaluate of the potential bronchoconstriction of the study treatment)
研究概览
简要总结
The CLI-05993AB6-03 Study is an interventional study designed to investigate the safety and efficacy of a new low global warming potential propellant (HFA-152a) compared to the currently approved one (HFA-134a) in the medication (CHF5993) in patients with moderate to severe asthma
详细描述
Outpatients attending the hospital clinics/study centers will be recruited. Moderate to severe controlled asthma adult subjects will be recruited. A total of 513 subjects will be randomised. The whole study will last approximately 16 weeks for each subject.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind multicentre, randomised, active-controlled, 2-arm, parallel-group
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
- •Subject's written informed consent obtained prior to any study related procedure;
- •Male and female adults aged ≥ 18 and ≤ 75;
- •Body mass index (BMI) within the range of 18.0 to 35.0 kg/m2 inclusive;
- •Non-smokers or ex-smokers who smoked < 10 pack-years (pack-years = the number of cigarette packs per day x the number of years) and stopped smoking > 1 year (6 months for e-cigarettes) prior to screening;
- •Diagnosis of asthma: physician-diagnosed asthma for at least
- •6 months and with diagnosis before the age of 50 years;
- •Stable asthma therapy: a stable treatment with medium/high doses of inhaled corticosteroids (ICS) + long-acting β-agonist (LABA) + long-acting muscarinic antagonist (LAMA) (fixed or free combination) or medium/high doses of ICS+LABA (fixed or free combination) for at least 4 weeks before screening (medium and high-dose ICS defined as BDP non-extrafine > 500-1000 μg and > 1000 μg respectively, or estimated clinical comparable dose).
- •Subjects must have a cooperative attitude and the ability to be trained to use correctly the pMDI inhalers and e-Diary, to be able to read/write, to be able to perform the required outcomes measurements (e.g., technically acceptable spirometry, e-Diary completion) and the ability to understand the risks involved.
排除标准
- •History of near fatal asthma, hospitalisation for asthma in intensive care unit which in the judgement of the Investigator may place the subject at undue risk, emergency room access for asthma in the previous 6 months before enrolment;
- •Asthma exacerbation requiring systemic corticosteroids (SCS) or emergency room admission or hospitalisation within 4 weeks prior to study entry and/or during the run-in period (to be checked again prior to randomisation);
- •Non-permanent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medecine
研究组 & 干预措施
Inhaler CHF5993 200/6/12.5 μg pMDI HFA-152a
Experimental
Active ingredients: BDP/FF/GB 200/6/12.5 μg per actuation; Excipients: HFA-152a propellant.
干预措施: CHF5993 200/6/12.5 μg pMDI HFA-152a (Drug)
Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a
Active Comparator
Active ingredients: BDP/FF/GB 200/6/12.5 μg per actuation; Excipients: HFA-134a propellant.
干预措施: Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a (Drug)
结局指标
主要结局
Relative change from pre-dose Forced Expiratory Volume in one second with (FEV1) (Safety Assessment to evaluate of the potential bronchoconstriction of the study treatment)
时间窗: Day 1
Relative change from pre-dose in FEV1 at the 10 min post-dose timepoint
次要结局
- Peak expiratory flow (PEF) change from baseline at each inter-visit period over the entire treatment period(Inter-visit, over the entire 12 weeks treatment period)
- To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (relative change from pre-dose FEV1)(Day 1, Day 7, Week 4, Week 12)
- Percentage of days without intake of rescue medication.(Inter-visit, over the entire 12 weeks treatment period)
- Change from baseline in Asthma Control Questionnaire 7 (ACQ 7) score.(At each planned on site study visit, during the entire 12 weeks treatment period.)
- To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (absolute change from pre-dose FEV1)(Day 1, Day 7, Week 4, Week 12)
- To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (number and percentage of subjects with a relative decrease from pre-dose in FEV1)(Day 1, Day 7, Week 4, Week 12)
- Change in the average daily use of rescue medication.(Inter-visit, over the entire 12 weeks treatment period)
- To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Absolute and relative changes from baseline in pre-dose FEV1)(Day 1, Day 7, Week 4, Week 12)
- To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Change from pre-dose in FEV1)(Day 1, Day 7, Week 12)
- Change on the average daily asthma symptoms.(Inter-visit, over the entire 12 weeks treatment period)
研究者
研究点 (231)
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