A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire
研究概览
简要总结
This study aims to evaluate the safety, tolerability and effectiveness of BTA798 on
- shortening the length and reducing the symptoms of human rhinovirus infection (also known as the common cold),
- controlling asthma symptoms, and
- lowering the risk of asthma symptoms worsening in subjects with asthma.
详细描述
Subjects with a previous diagnosis of asthma will be pre screened within 90 days prior to enrolment. If a subject develops symptoms of human rhinovirus (HRV) infection they will visit the site for assessment. Symptomatic subjects meeting all eligibility criteria will be invited to enroll.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged 18-70 years
- •Diagnosis of asthma consistent with Global Initiative for Asthma (GINA) steps 1 to 3
- •Presumptive human rhinovirus infection
排除标准
- •Current severe asthma exacerbation
- •Severe asthma, GINA steps 4 or higher
- •Uncontrolled or clinically significant medical condition, disease or event which could impact subject safety and/or study evaluations and/or compliance to the protocol
- •Current smoker, ex-smoker of <1 year, or history of smoking >/=10 pack years.
研究组 & 干预措施
BTA798
干预措施: BTA798 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire
时间窗: Days 2-4
Daily Change in WURSS-21 Severity Score Averaged over Days 2 to 4. The Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire is an evaluative illness-specific outcomes instrument designed to assess the severity of cold symptoms and the impact of the common cold (range 0-140), with higher scores indicating more symptoms and functional impairment.
次要结局
未报告次要终点