A Safety, Tolerability and Efficacy Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects Birth to 48 Months Old With Reactive Airways Disease in an Acute Setting
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 117
- 主要终点
- Maximum decrease in Respiratory Status Scale© total score
研究概览
简要总结
The purpose of this study is to compare the efficacy of two dose levels of levalbuterol compared with one dose level of racemic albuterol in pediatric subjects aged birth to 48 months old.
详细描述
A double-blind, randomized, active-controlled, multicenter, parallel-group trial of levalbuterol in pediatric subjects presenting with acute reactive airways disease. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject, male or female, must be between the ages of birth to 48 months inclusive at the time of consent.
- •Subject must have experienced at least one previous episode or have a history of reactive airways disease.
- •Subject must have an Oxygen saturation ≥ 90% at room air or with no more than 2 L/min supplemental Oxygen.
排除标准
- •Subject who has participated in an investigational drug study within 30 days prior to study start, or who has previously participated in this study.
- •Subject with a known sensitivity to levalbuterol or racemic albuterol, including Ventolin® or any of the excipients contained in any of these formulations.
- •Subject using any prescription drug with which levalbuterol or racemic albuterol sulfate administration is contraindicated.
研究组 & 干预措施
C
Racemic albuterol (0.63, 1.25 mg or 2.5 mg); the first three doses will be delivered every 20 minutes for the first hour. Up to three additional doses may be given every 40 minutes thereafter. Additional doses may be administered at the investigator's discretion.
Period II: Double blind, active-treatment period following discharge from the Emergency Department or Physician's Office. Subject will receive TID double-blind dosing. Period III: Double blind, active-treatment period following Visit 2. Subjects will receive double-blind dosing at the discretion of the investigator (PRN to TID).
干预措施: Albuterol HCl Inhalation Solution (Drug)
A
Low dose levalbuterol (0.15 mg, 0.31 mg or 0.63 mg); the first three doses will be delivered every 20 minutes for the first hour. Up to three additional doses may be given every 40 minutes thereafter. Additional doses may be administered at the investigator's discretion.
Period II: Double blind, active-treatment period following discharge from the Emergency Department or Physician's Office. Subject will receive TID double-blind dosing. Period III: Double blind, active-treatment period following Visit 2. Subjects will receive double-blind dosing at the discretion of the investigator (PRN to TID).
干预措施: Levalbuterol HCl Inhalation Solution (Drug)
B
High dose levalbuterol (0.31 mg, 0.63 mg or 1.25 mg); the first three doses will be delivered every 20 minutes for the first hour. Up to three additional doses may be given every 40 minutes thereafter. Additional doses may be administered at the investigator's discretion.
Period II: Double blind, active-treatment period following discharge from the Emergency Department or Physician's Office. Subject will receive TID double-blind dosing. Period III: Double blind, active-treatment period following Visit 2. Subjects will receive double-blind dosing at the discretion of the investigator (PRN to TID).
干预措施: Levalbuterol HCl Inhalation Solution (Drug)
结局指标
主要结局
Maximum decrease in Respiratory Status Scale© total score
时间窗: Day 0: Approximately 5-10 minutes after each dose until subject is admitted or discharged
次要结局
- Time to meet discharge criteria or clinical decision to discharge.(Days 0-7)
- Time to maximum decrease in Respiratory Status Scale© total score.(Days 0-7)
- Individual Respiratory Status Scale© items.(Days 0-7)
- Time to hospitalization.(Days 0-7)
- Rate of hospitalization.(Days 0-7)