A Phase 2, Single-Dose, Randomized, Active and Placebo Controlled, Four-Period, Cross-Over Study of the Safety and Efficacy of Intranasal Epinephrine After Administration of ARS -1 or Albuterol in Subjects With Persistent Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 6
- 主要终点
- Effect of ARS-1 versus Albuterol and placebo
研究概览
简要总结
ARS-1 is being developed for patients as a needleless alternative route of epinephrine administration for the management of refractory asthma symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Is a male or female subject between the ages of 12 and 65 years, inclusive.
- •2. Asthma that has been stable for at least four weeks prior to screening as defined by clinical history.
- •3. Reversible bronchoconstriction.
- •4. Has body weight more than 30 kilogram (kg) and body mass index between 18 and 34 kg/m², inclusive.
- •5. Has no medical history of hypertension and cardiovascular disease in the last 10 years.
- •6. At screening, has stable vital signs.
排除标准
- •1. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition.
- •2. Patients receiving beta blocker.
- •3. Has any clinically significant medical condition or physical exam finding as deemed inappropriate by the Investigator.
- •4. Has abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal electrocardiogram.
- •5. Has mucosal inflammatory disorders.
- •6. Has had significant traumatic injury, major surgery or open biopsy within 30 days prior to study screening.
研究组 & 干预措施
Sequence 1
ARS 2mg: albuterol: Placebo: ARS 1mg
干预措施: Albuterol MDI (Drug)
Sequence 2
ARS 1mg: Placebo: albuterol: ARS 2mg
干预措施: Albuterol MDI (Drug)
Sequence 1
ARS 2mg: albuterol: Placebo: ARS 1mg
干预措施: ARS-1 2mg (Drug)
Sequence 1
ARS 2mg: albuterol: Placebo: ARS 1mg
干预措施: Placebo (Drug)
Sequence 1
ARS 2mg: albuterol: Placebo: ARS 1mg
干预措施: ARS-1 1 mg (Drug)
Sequence 2
ARS 1mg: Placebo: albuterol: ARS 2mg
干预措施: ARS-1 1 mg (Drug)
Sequence 2
ARS 1mg: Placebo: albuterol: ARS 2mg
干预措施: Placebo (Drug)
Sequence 2
ARS 1mg: Placebo: albuterol: ARS 2mg
干预措施: ARS-1 2mg (Drug)
结局指标
主要结局
Effect of ARS-1 versus Albuterol and placebo
时间窗: From baseline (timepoints 0) to 1 hour
Difference in forced expiratory volume in 1 second (FEV1) based on area under the curve (AUC)
Effect of ARS-1 Versus Albuterol and Placebo
时间窗: From baseline (timepoints 0) to 1 hour
Difference in forced expiratory volume in 1 second (FEV1) based on area under the curve (AUC)
次要结局
未报告次要终点