Epinephrine Inhalation Aerosol USP, an HFA-MDI: Clinical Study-C For Evaluation Of Efficacy And Safety In Asthma Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 373
- 试验地点
- 31
- 主要终点
- Change in Area Under the Curve (AUC) versus placebo
研究概览
简要总结
This clinical study evaluates the 12-week efficacy and safety of Epinephrine HFA Inhalation Aerosol HFA the proposed HFA formulation of metered dose inhaler (MDI) of Epinephrine, in comparison to a Placebo-HFA control MDI and the currently marketed Primatene® Mist (epinephrine CFC inhaler), in adolescent and adult subjects with asthma.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with documented asthma, requiring inhaled epinephrine or beta 2-agonist treatment.
- •No significant changes in asthma therapy and no asthma-related hospitalization or emergency visits, within 4 weeks prior to Screening
- •Can tolerate withholding treatment with inhaled bronchodilators and other allowed medications for the minimum washout period.
- •Demonstrating a Screening Baseline FEV1 that is 50 - 90% of predicted normal value.
- •Demonstrating at least a 12% Airway Reversibility.
- •Demonstrating satisfactory techniques in the use of metered-dose inhaler and a hand held peak expiratory flow meter.
- •Female patients of child-bearing potential must be non-pregnant and non-lactating at Screening and throughout the study, and must use an acceptable method of contraception during the study.
排除标准
- •A smoking history of 10-pack years, or having smoked within 12 months of screening.
- •Any current or past medical conditions that, per investigator discretion, might significantly affect responses to the study drugs, other than asthma.
- •Concurrent clinically significant diseases.
- •Known intolerance or hypersensitivity to any component of the study drugs.
- •Recent infection of the respiratory tract, before screening.
- •Use of prohibited medications.
- •Having been on other investigational drug/device studies in the last 30 days prior to screening.
- •Known or highly suspected substance abuse.
研究组 & 干预措施
Arm T
Arm T is the experimental treatment arm consisting of 2 x 125 mcg/inhalations of E004, QID, with 4-6 hr intervals
干预措施: epinephrine inhalation aerosol (Drug)
Arm P
Placebo comparator as 2×Placebo QID, with 4-6 hr intervals
干预措施: Placebo (Drug)
Arm A
Active comparator, Primatene Mist, 2×220 mcg/inhalation, QID, with 4-6 hr intervals
干预措施: epinephrine inhalation aerosol (Drug)
结局指标
主要结局
Change in Area Under the Curve (AUC) versus placebo
时间窗: at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose
Serial FEV1 measurements to demonstrate the mean AUC of change in percent FEV1 from same-day baseline of E004 (Treatment T; Epinephrine-HFA) versus Placebo-HFA (Treatment P) is the primary efficacy endpoint.
次要结局
- Monitor vital signs(2, 10, 20, 60, and 360 min after dosing)
- Blood glucose and potassium(baseline, and at 15 and 120 min post-dose)
- Cardiac rhythm(at baseline, 2, 10, 20, and 60 min post-dose)