NCT06029595终止2 期
A 52-week, Randomised, Double Blind, Multicentre, 2-arm Parallel Group Trial Assessing Efficacy of CHF6001 (Total Daily Dose 3200μg) Dry Powder Inhaler (DPI) add-on to Maintenance Medium or High Dose of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists in Subjects With Uncontrolled Asthma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 517
- 试验地点
- 369
- 主要终点
- Number of Asthma exacerbation over 52 weeks of treatment
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of CHF6001 (Tanimilast) as add-on to maintenance of inhaled corticosteroids in combination with Long-acting ß2-agonists in the target patient population. (TANGO)
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)
盲法说明
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
- •Subject's written informed consent
- •Male or female subjects aged ≥18 and ≤75 years
- •A documented history of physician-diagnosed asthma for at least 1 year and with diagnosis before the age of 50 years
- •Stable asthma therapy: a stable maintenance treatment with medium to high dose of inhaled corticosteroids plus long acting β2 agonists for at least 3 months prior to screening
- •A prebronchodilator FEV1 ≤80% of the predicted normal value
- •Bronchodilator responsiveness after inhalation of salbutamol or equivalent
- •Evidence of poorly controlled or uncontrolled asthma as based on an ACQ-7 score ≥1.5
- •History of asthma exacerbations : at least 1 asthma exacerbation leading to hospitalisation or 2 or more asthma exacerbations within the last 12 months
- •A cooperative attitude and ability to use inhalers and to comply with study procedures
排除标准
- •e-Diary completion compliance <75% during run-in
- •History of near fatal asthma or of a past hospitalisation for asthma in intensive care unit
- •Recent exacerbation or respiratory tract infection within 4 weeks prior to screening visit or during the run-in period
- •Subjects using systemic corticosteroids medication in the 4 weeks or slow-release corticosteroids in the 12 weeks prior to randomisation
- •Asthma requiring use of biologics
- •Respiratory disorders other than asthma: subjects with known respiratory disorders other than asthma
- •Subjects with a history of lung volume resection
- •Current smokers, ex-smokers with a smoking history of ≥10 pack-years or current use of inhaled or oral cannabis products.
- •Subjects with cancer or history of cancer
- •Subjects with cardiovascular diseases
- •Subjects with any abnormal and clinically significant 12-lead ECG
- •Subjects with previous medical history, evidence of an uncontrolled intercurrent illness, or any clinically relevant abnormal findings in haematology, clinical chemistry, or urinalysis
- •Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation or behaviour
- •Patients mentally or legally incapacitated or patients accommodated in an establishment
- •Subjects with liver diseases
- •Drugs with hepatoxicity potential
- •Subjects with contra-indications to IMPs:
- •Subjects with history alcohol/drug abuse
- •Subjects with major surgery in the 3 months prior to screening visit or planned during the trial
- •Subjects treated with non-potassium sparing diuretics, nonselective β-blocking drugs, quinidine, quinidine like anti-arrhythmic, or any medication with a QTc prolongation potential or a history of QTc prolongation
- •Subjects treated with monoamine oxidase inhibitors (MAOIs) and tricyclic anti-depressants
- •Subjects receiving any therapy that could interfere with the study drugs
- •Participation in another investigational trial
- •Documented coronavirus disease 2019 (COVID-19) diagnosis within the last 2 weeks
- •Subjects having received a vaccination within 2 weeks prior to screening or during the run-in period.
- •For females only: pregnant or lactating women
结局指标
主要结局
Number of Asthma exacerbation over 52 weeks of treatment
时间窗: Over 52 weeks
Number of Asthma exacerbation over 52 weeks of treatment (Asthma exacerbations defined as severe event with worsening of asthma requiring at least 3 days of SCS use with or without emergency visit or hospitalization)
次要结局
- Number of asthma exacerbation and asthma worsening over 52 weeks of treatment(Up to 52 weeks)
- ACQ-7 responders(week 4, week 26 and week 52)
- Change from baseline in ACQ-7 and ACQ-6(week 4, week 26 and week 52)
- Change from baseline in Mini-AQLQ(week 4, week 26 and week 52)
- Change from baseline (run-in period) to each inter-visit period and to the entire treatment period in pre dose morning/evening PEF;(Up to 52 weeks)
- Change from baseline in pre-dose FEV1(week 4, week 26 and week 52)
- Time to first asthma exacerbation;(Up to 52 weeks)
- Time to first asthma exacerbation or asthma worsening(Up to 52 weeks)
- Change from baseline in pre-dose FVC(Week4, Week 52 and Week 26)
- Change from baseline to each inter-visit period and to the entire treatment period in the average rescue medication use (number of puffs/day) and asthma symptoms score(Up to 52 weeks)
- Change from baseline to each inter-visit period and to the entire treatment period in the percentage of rescue medication-free days, asthma symptoms-free days and asthma control days.(Up to 52 weeks)
研究者
研究点 (369)
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