NCT01476904已完成3 期
A 3-month Safety Evaluation Extension to the 12-week E004-C Study in Asthma Patients (A Double Blinded, Placebo-controlled, Parallel, 3-month Safety Study in Adolescent and Adult Patients With Asthma)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 27
- 主要终点
- Adverse Events
研究概览
简要总结
E004-C2 is a continuation of E004-C for safety evaluations with additional 3 months to be able to assess the 6-month safety profile for E004 (epinephrine inhalation) versus placebo in a double-blinded manner.
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
- •Only subjects who have successfully completed the E004-C study within the last 135 days or those who are actively enrolled in the current study E004-C at the time of the study extension initiation
- •Male and female asthma patients aged 12 - 75 years
- •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
- •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
Experimental
Arm T is the experimental treatment arm consisting of 2 x 125 mcg/inhalations of epinephrine inhalation, QID, with 4-6 hr intervals
干预措施: Epinephrine inhalation (Drug)
Arm P
Placebo Comparator
Arm P is a placebo comparator consisting of 2× 0 mcg of placebo inhalations, QID, with 4-6 hr intervals
干预措施: Placebo (Drug)
Arm A
Active Comparator
Arm A is an active comparator, Primatene Mist, consisting of 2× 220 mcg/inhalation, QID, with 4-6 hr intervals
干预措施: Primatene Mist (Drug)
结局指标
主要结局
Adverse Events
时间窗: up to 12 weeks
Recording of all adverse events experienced during the course of the study
次要结局
- Change in 12 lead ECG including QT/QTc analysis(Study visit 4, 8 and 12, greater than one hour after last dose)
- Asthma Exacerbations(up to 12 weeks)
研究者
研究点 (27)
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