NCT07059767招募中2 期
A Phase IIa, Double-blind, Randomized, Placebo-controlled Trial in Participants With Asthma to Evaluate the Impact of Intranasal ETH47 on the Development of Asthma-related Symptoms Following Rhinovirus Challenge
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Ethris GmbH
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Change in peak of total lower respiratory symptoms score (LRSS)
研究概览
简要总结
A Phase IIa trial in participants with asthma to evaluate the impact of intranasal ETH47 on the development of asthma-related symptoms following rhinovirus challenge
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Participants aged ≥18 and ≤65 years at the time of obtaining informed consent.
- •Diagnosis of clinical asthma (>12% reversibility following short acting beta 2 agonist (SABA) treatment or PC20 methacholine challenge of <8 mg/mL).
- •Stable (no change in medication or dose) asthma maintenance therapy with inhaled glucocorticosteroids (ICS) or ICS + long acting beta 2 agonist (LABA) for at least 3 months prior to dosing.
- •Clinically stable with no exacerbations within 3 months prior to dosing.
- •Sero-negative test result to RV-A
- •Participants must agree to use contraception methods (if applicable).
排除标准
- •Any cold symptom within the last month such as sore throat, sneezing, rhinorrhoea, malaise, nasal obstruction or cough.
- •Evidence of current allergic rhinitis, including perennial allergic rhinitis, or rhinosinusitis or nasal polyps.
- •History of or current diagnosis of chronic obstructive pulmonary disease, emphysema, cystic fibrosis or bronchiectasis.
- •The evidence of any other historic, active or chronic disease following a detailed medical and surgical history which, in the Investigator's judgement, puts the participant at risk due to participation in the trial, may influence the results of the trial, or the participant's ability to participate in the trial. This includes a history of emergency room visits or hospital admissions due to common cold.
- •Current vaper or smoker, or ex-smoker who stopped within the last 12 months or with a >5 year pack history; current vapers may be included if willing to stop prior to Baseline.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
ETH47
Experimental
干预措施: ETH47 (Drug)
结局指标
主要结局
Change in peak of total lower respiratory symptoms score (LRSS)
时间窗: Day 1 to Day 14
7 Questions on lower respiratory symptoms are scored from 0-3 (absent, mild moderate, severe)
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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