NCT01460511已完成3 期
Phase III Study of Epinephrine Inhalation Aerosol for Evaluation of Efficacy and Safety of E004 in Children 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
- 70
- 试验地点
- 8
- 主要终点
- Primary Efficacy Endpoint AUC of FEV1's relative change
研究概览
简要总结
This is a multi-center, randomized, double-blinded, placebo-controlled, parallel, 4-week study in 60 pediatric patients (4-11 years old) with asthma, comparing E004 with Placebo HFA-MDI in pediatric patients who are 4-11 years of age 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Generally healthy male, and premenarchal female, children aged 4 - 11 years upon Screening.
- •With documented asthma, requiring inhaled epinephrine or beta2-agonist treatment, with or without concurrent anti-inflammatory therapies for at least 6-months prior to Screening.
- •Being capable of performing spirometry for FEV1
- •Satisfying criteria of asthma
- •Can tolerate withholding treatment with inhaled bronchodilators and other allowed medications for the minimum washout periods
- •Demonstrating a Screening Baseline FEV1 that is 50 - 90% of Polgar predicted normal value.
- •Demonstrating an Airway Reversibility,
- •Demonstrating satisfactory techniques in the use of a metered-dose inhaler (MDIs) and a hand held peak expiratory flow meter, after training.
- •Has been properly consented to participate in this study.
排除标准
- •Any current or past medical conditions that, per investigator discretion, might significantly affect pharmacodynamic responses to the study drugs
- •Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, or malignant diseases.
- •Known intolerance or hypersensitivity to any component of the study drugs
- •Recent infection of the respiratory tract
- •Use of prohibited medications
- •Having been on other investigational drug/device studies in the last 30 days prior to screening.
研究组 & 干预措施
P - Placebo-HFA
Placebo Comparator
Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID
干预措施: Placebo-HFA (Drug)
T - E004 (Epinephrine Inhalation Aerosol) HFA-MDI
Experimental
E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID
干预措施: E004 (Epinephrine Inhalation Aerosol) HFA-MDI (Drug)
结局指标
主要结局
Primary Efficacy Endpoint AUC of FEV1's relative change
时间窗: Visit 1 and Visit 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose
bronchodilator effect expressed as AUC of FEV1's relative change (from the same day baseline) versus time, defined as AUC of ΔFEV1%.
次要结局
- AUC of FEV1 volume changes (AUC of change in FEV1)(Visit 1 and Visit 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose)
- Maximum of change in FEV1% (Fmax)(Visit 1 and Visit 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose)
- Time to onset of bronchodilator effect (to onset), determined the time point (within 60 minutes) where FEV1 first reaches ≥12% above Same-Day Baseline.(Study Visits 1and 3 within 60 minutes post dose)
- Albuterol HFA usage for rescue relief of acute asthma symptoms(Study Visits 1, 2, and 3, within 30 min predose)
- Curves of change in FEV1, and change in FEV1%, versus time(Visit 1 and Visit 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose)
- The time to peak FEV1 effect (tmax), defined as the time of Fmax.(Study Visits 1 and 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose)
- Duration of efficacy (duration), defined as the total length of time when ΔFEV1% reaches and stays ≥12% above Same-Day Baseline.(Study Weeks 1and 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose)
- Percentage of positive responders (R%), including all subjects whose Fmax reaches ≥12% above Same-Day Baseline.(Study Weeks 1 and 3 within 60 minutes post dose)
- Mean daily morning pre-dose Peak Expiratory Flow Rate (PEF)(daily pre-dose)
- Evaluation of Vital Signs(predose, and 3, 20, 60, 360 minutes post-dose)
- 12-lead ECG(Pre-dose and , 3, 20 and 60 minutes post-dose (Study Visits 1 and 3))
研究者
研究点 (8)
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