NCT05985694已完成1 期
A Single-blind (Patient-blind), Randomized, Placebo-controlled, Intranasal Administration Study on Mechanisms and Potential Efficacy of AD17002 in Subjects With Poorly Controlled, Moderate to Severe Eosinophilic Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- FEV1 improvement
研究概览
简要总结
This clinical trial aims to investigate patients with poorly controlled, moderate to severe eosinophilic asthma. The main questions it seeks to answer are
- Could the AD17002 intranasal immunomodulator improve the clinical condition of eosinophilic asthmatic patients?
- Could patients self-administer AD17002 via the intranasal route?
- Is the AD17002 at multiple doses safe for asthmatic patients?
- Participants will be asked to self-administer two doses per week for a total of 6 weeks (11 doses). A diary on AD17002 usage, adverse events, and reliever medication will be recorded.
详细描述
This study was conducted to determine the potential efficacy and mechanism of AD17002 as an immunomodulator in attenuating the severity of clinical manifestations in patients with unstable, moderate-to-severe eosinophilic asthma. Patients with clinical history and ongoing eosinophilic asthma will be randomly assigned to either AD17002 (10 μg or 20 μg) or placebo, per 3-4 days, in a 1:1 ratio, in a single-blinded (patient-blinded) fashion. The nasal administration will be self-administered by participants. Progression and improvement in asthmatic symptoms will be recorded. All study subjects will sign ethics committee-approved informed consent forms before participating in any trial-related activities. Subjects who participate in this trial of AD17002 will provide information about the dosing, efficacy, and safety of the new indication that will guide its future clinical use.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject 20-80 years of age on the day of signing informed consent
- •Subject who is not a current smoker with poorly controlled, moderate to severe eosinophilic asthma based on GINA 2022 criteria.
- •The subject is diagnosed with asthma.
- •Subjects who have the post-bronchodilator reversibility of Forced expiratory volume 1 (FEV1) of ≥ 12% and ≥ 200 mL in response to a SABA at the screening visit or documented in the medical chart within 3 months of the screening visit.
- •Subjects who have ≥3% eosinophil counts in the induced sputum within 7 days of Visit
- •Subjects with ACT scores ≤ 19 under regular low to moderate-dose inhaled corticosteroids (ICS) and/or a combination with inhaled long-acting beta 2 agonists for at least 3 months before the Screening Visit.
- •Have a negative serum pregnancy test at the screening, and randomization visits (female subjects of childbearing potential). A female subject who is of reproductive potential agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control within the projected duration of the trial. Acceptable birth control methods are intrauterine devices, hormonal contraception, diaphragm with spermicide, contraceptive sponge, condoms, and vasectomy, as per local regulations or guidelines.
- •A female subject who is not of reproductive potential is eligible without requiring the use of contraception. A female subject who is not of reproductive potential is defined as one who has either
- •Reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone levels in the postmenopausal range as determined by the laboratory, or 12 months of spontaneous amenorrhea),
- •Six weeks postsurgical documented total hysterectomy and/or bilateral salpingo-oophorectomy, or
- •Bilateral tubal ligation.
- •Subject or the subject's legal representative understands the trial procedures, alternative treatments available, and risks involved with the trial, and voluntarily agrees to participate by giving written informed consent.
- •Provide written informed consent for the trial and be willing to adhere to dose and visit schedules.
排除标准
- •Subjects with serious underlying chronic illness or severe systemic disease, including SLE, malignant diseases, uremia and heart failure, or abnormal liver function.
- •Subjects without a recent respiratory tract infection within 3 weeks before the study.
- •Subjects without a recent COVID-19 infection within 1 month before study.
- •Subjects with clinically important lung disease, including but not limited to COPD (Chronic Obstructive Pulmonary Disease), chronic respiratory infection, lung cancer, etc.
- •Arrhythmia, myocardial infarction, or stroke in the last 3 months.
- •Active COVID-19 disease (SARS-CoV-2 Lateral flow tests (LFA)-positive) at Screening.
- •A clinical history of persistent allergic asthma or rhinitis caused by an allergen to which the subject is regularly exposed and sensitized.
- •A clinical history of active chronic sinusitis (> 3 months).
- •Any clinically relevant chronic disease (>=3 months duration) (e.g. cystic fibrosis, malignancy, renal or hepatic insufficiency).
- •Subject with a documented history of Bell's palsy.
- •The subject has any nasal condition that could confound the efficacy or safety assessments.
- •Immunosuppressive treatment (ATC code L04 or L01) within 3 months before the screening visit (except the specified concomitant medications for allergy and asthma symptoms).
- •Has unstable or severe asthma, as judged by the clinical Investigator, or a subject who has experienced a life-threatening asthma attack or an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids (but allowing SABA) at any time within the last 3 months before Screening Visit.
- •Has asthma requiring high-dose oral corticosteroid (OCS) within the last 3 months before Screening Visit.
- •Has a history of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, unknown cause, or inhalant allergen.
- •Is pregnant or expecting to conceive within the projected duration of the trial.
- •Is nursing at randomization and within the projected duration of the trial?
- •Has had previous exposure to the study drug or Flu Vaccine AD
- •The subject is receiving ongoing treatment with any specific immunotherapy at the time of the Screening Visit.
- •Has a known history of allergy, hypersensitivity, or intolerance to investigational medicinal products, rescue medications, or self-injectable epinephrine.
研究组 & 干预措施
Cohort 1 Placebo
Placebo Comparator
Formulation buffer
干预措施: Placebo (Drug)
Cohort 1 Low dose
Experimental
Formulation buffer + 10 μg AD17002
干预措施: AD17002 (Drug)
Cohort 2 Placebo
Placebo Comparator
Formulation buffer
干预措施: Placebo (Drug)
Cohort 2 High dose
Experimental
Formulation buffer + 20 μg AD17002
干预措施: AD17002 (Drug)
结局指标
主要结局
FEV1 improvement
时间窗: Day 1 to Day 78
Lung function tests with spirometry
次要结局
- Change to the use of Short-Acting Beta Agonists (SABA)(Day 1 to Day 78)
- Fractional exhaled nitric oxide (FeNO) change(Day 1 to Day 78)
- changes of sputum eosinophil counts(Day 1 to Day 78)
- Asthma Control Test (ACT) scores improvement(Day 1 to Day 78)
- Corticosteroid used to control asthma(Day 1 to Day 78)
- Immunological biomarkers of sputum(Day 1 to Day 78)
- Immunological biomarkers of serum(Day 1 to Day 78)
- Peripheral eosinophil count(Day 1 to Day 78)
- Adverse events_clinical visit(Day 1 to Day 36 and Day 78)
- Adverse events-Diary(Day 1 to Day 78)
研究者
研究点 (1)
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