2025-521456-35-00招募中2 期
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. [TRECONY]
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 112
- 主要终点
- • Change from baseline in FEV1 AUC0-4h on Day 1 • Change from baseline in pre-dose FEV1 on Day 28
研究概览
简要总结
To demonstrate the therapeutic equivalence of CHF5993 pMDI HFA-152a versus (vs.) CHF5993 pMDI HFA-134a in terms of change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from time zero to 4 hours (h) (AUC0-4h) on Day 1 and in pre-dose FEV1 on Day 28 in adults with mild to moderate, controlled/partly controlled asthma
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Informed consent: obtained prior to any study-related procedure
- •Rescue medication: subjects must be able to replace their current rescue medication with a salbutamol (i.e. albuterol) inhaler for use as needed for the duration of the study
- •Current therapy: subjects must be able to safely discontinue their asthma medications (ICS with or without LABA) during the run-in period and for the remainder of the study
- •Spacer non-use: subjects must be able to inhale the study treatment without using a spacer
- •Subjects must have a willingness and ability to: a. Be trained to correctly use the pMDI inhalers and the electronic diary (e-Diary); b. Read/write; c. Perform all study-related procedures, including technically acceptable spirometry and e-Diary completion; d. Understand the risks involved
- •Female subjects: a. Woman of childbearing potential (WOCBP) using a highly effective birth control method (refer to protocol for more details) or b. Women of non-childbearing potential
- •Sex and age: male and female adults aged ≥18 and ≤75 years
- •Body mass index: within the range of 18.0 to 35.0 kg/m2 inclusive
- •Smoking status: non-smokers or ex-smokers who smoked ≤10 pack-years prior to screening
- •Diagnosis of asthma: documented physician-diagnosed asthma for at least 6 months prior to screening and with diagnosis before the age of 50 years
- •Stable asthma therapy: a stable maintenance treatment for at least 4 weeks prior to screening with: a.low or medium doses of ICS alone; or b.low or medium doses of ICS + LABA (fixed or free combination). Low and medium doses of ICS are defined as non-extrafine BDP 200-500 μg and >500-1000 μg respectively, or estimated clinically comparable dose per the Global Initiative for Asthma 2024
- •Asthma control: controlled or partly controlled based on an Asthma Control Questionnaire - 7 Items (ACQ-7) score <1.5 at screening and at randomisation
- •Lung function: pre-BD FEV1 >40% and <90% of the predicted normal value, after appropriate wash-out from BDs, at the Screening Visit (V1)
- •Bronchodilator responsiveness: 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 high-risk asthma: 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
- •Electrocardiogram (ECG) criteria: any clinically significant abnormal 12-lead ECG that, in the Investigator’s opinion, would affect efficacy or safety evaluations or place the subjects at risk
- •ECG QTcF: male subjects with a QT interval corrected using Fridericia’s formula (QTcF) >450 milliseconds (ms) and female subjects with a QTcF >470 ms at Screening Visit (V1) are not eligible
- •Other medical conditions: previous medical history, evidence of an uncontrolled, severe, intercurrent illness, or any clinically relevant abnormal findings in haematology, clinical chemistry, or urinalysis
- •Concurrent diseases: subjects with a medical history or current diagnosis of narrow-angle glaucoma, symptomatic prostatic hypertrophy, urinary retention, or bladder neck obstruction that, in the opinion of the Investigator, would prevent the use of anticholinergic agents
- •Subjects receiving non-selective β2-blockers, quinidine and quinidine-like anti-arrhythmics, tricyclic anti-depressants, monoamine oxidase inhibitors, cytochrome P450 3A4 inhibitors and non-potassium sparing diuretics within 4 weeks prior to screening (unless the diuretic is administered as a fixed-dose combination with a potassium-conserving drug)
- •Contra-indications to IMPs. For warnings, eligibility will be judged by the Investigator
- •History of hypersensitivity to any components of the study treatments or a history of other allergies that, in the opinion of the Investigator, contraindicates the subject’s participation
- •Non-permitted concomitant medications: subjects receiving treatment with one or more drugs listed in the non-permitted concomitant medications section
- •Clinical evidence of candidiasis at the oropharyngeal examination at screening or randomisation (to be re-checked at randomisation)
- •Documented coronavirus disease 2019 (COVID-19) diagnosis within 2 weeks prior to screening, or associated complications/symptoms, which have not resolved within 14 days prior to screening (to be re-checked at randomisation)
- •Recent asthma exacerbation: 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 (to be checked again at randomisation)
- •Alcohol/drug abuse: subjects with a known or suspected history of alcohol and/or substance/drug abuse within 12 months prior to screening (to be re-checked at randomisation)
- •Participation in other investigational studies: subjects who have received any investigational drug within the 30 days (60 days for biologics) or approximately 5 half-lives of the investigational drug (whichever is longer) prior to screening, or who have been previously randomized in this study, or who are currently participating in another clinical study (to be re-checked at randomisation)
- •Pregnant or lactating women
- •Run-in compliance: e-Diary completion <75% and run-in treatment compliance <75% at randomisation
- •Vaccination: subjects having received a vaccination within 2 weeks prior to screening or during the run-in period (to be rechecked at randomisation)
- •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: a. High dose ICS; b. Long-acting muscarinic antagonist (LAMA); c. Systemic, depot or slow-release corticosteroids within 12 weeks prior to screening; d. Any other asthma treatments (e.g. cromolyn sodium, nedocromil sodium, leukotriene modifiers) within 4 weeks prior to screening; e. Any biologic therapy (e.g. omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab) within 6 months prior to screening
- •Respiratory disorders other than asthma: any concomitant respiratory disorder other than asthma that, in the opinion of the Investigator and/or Medical Monitor, will interfere with the evaluation of the investigational medicinal product (IMP) or interpretation of subject safety or study results
- •Lung resection: subjects with a history of lobectomy, pneumonectomy or other sizable lung volume resection (total volume of lung removed >25%)
- •Lower respiratory tract infection: subjects with lower respiratory tract infection that required use of antibiotics, if unresolved within 4 weeks prior to screening or if occurring during the run-in period (to be re-checked at randomisation)
- •Lung cancer and history of lung cancer: subjects with and active diagnosis of lung cancer or a history of lung cancer
- •Subjects with active cancer or a history of cancer (other than lungs) with less than 5 years disease-free survival time (whether or not there is evidence of local recurrence or metastases). Localised carcinoma (e.g. basal cell carcinoma, in situ carcinoma of the cervix adequately treated) is acceptable
研究组 & 干预措施
CHF5993 pMDI (100) -152a
Test
干预措施: CHF5993 pMDI (100) -152a (Drug)
CHF5993 pMDI HFA-152a
Auxiliary
干预措施: CHF5993 pMDI HFA-152a (Drug)
Trimbow 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution
Comparator
干预措施: Trimbow 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution (Drug)
结局指标
主要结局
• Change from baseline in FEV1 AUC0-4h on Day 1 • Change from baseline in pre-dose FEV1 on Day 28
• Change from baseline in FEV1 AUC0-4h on Day 1 • Change from baseline in pre-dose FEV1 on Day 28
次要结局
- Relative and absolute change from pre-dose FEV1 at all post-dose timepoints at each visit
- Number and percentage of subjects with a >15% relative decrease from pre-dose in FEV1 at any post-dose timepoint at each visit
- Change from pre-dose FEV1 area under the curve from time 0 to 2 h (AUC0-2h) on Day 28
- Change from baseline (Day 1) in ACQ-7 scores on Day 28
- Average daily use of rescue medication (number of puffs/day), percentage of days without intake of rescue medication and percentage of asthma control days during the TP
- Average morning and evening PEF and average daily symptoms during TP
研究者
Clinical Project Manager
Scientific
Chiesi Farmaceutici S.p.A.
研究点 (112)
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