A Safety and Tolerability Study of Levalbuterol Tartrate HFA Inhalation Aerosol Metered Dose Inhaler (MDI) in Pediatric Subjects Birth to ≤ 48 Months of Age With Reactive Airways Disease in an Acute Setting
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 17
- 主要终点
- The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events.
研究概览
简要总结
This is a study of levalbuterol tartrate HFA inhalation aerosol MDI in pediatric subjects birth to ≤ 48 months of age who go to the Emergency Department (ED) or their physician's office with an acute bronchospasm. Subjects presenting to the ED or physician's office with an acute bronchospasm must have a history of reactive airways disease, based on subjects' parent/guardian report.
详细描述
This is a study to determine the safety and tolerability of cumulative dosing with levalbuterol tartrate HFA inhalation aerosol MDI using a valved holding chamber and facemask in pediatric subjects birth to ≤ 48 months of age with acute bronchospasm. It is a randomized, double-blind, parallel-group, multicenter, trial of 3 doses of levalbuterol tartrate HFA inhalation aerosol MDI in pediatric subjects birth to ≤ 48 months of age who present to either the Emergency Department (ED) or their physician's office with an acute bronchospasm. Subjects presenting to the ED or physician's office with an acute bronchospasm must have a history of reactive airways disease, based on subjects' parent/guardian report.
Eligible subjects whose parent(s) or legal guardian(s) provide written informed consent to participate will be randomized to 1 of 2 treatments. Treatment 1 consists of 3 doses, with each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA [cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol]); Treatment 2 consists of 3 doses, with each dose comprised of 8 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff [cumulative dose of 1080 mcg of levalbuterol tartrate HFA inhalation aerosol]). For each Treatment, study medication will be administered every 20 minutes over a period of 1 hour for three doses.
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
- — 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female from birth to 48 months of age, inclusive, whose parent(s) or legal guardian(s) provide written informed consent prior to study participation and are willing to comply with study procedures.
- •Subject experiencing acute bronchospasm requiring a bronchodilator and who have a history of wheezing.
排除标准
- •Subject with a severe illness that, in the opinion of the Investigator, could jeopardize subject safety.
- •Subject received ≥ 8 puffs (MDI) of a beta-2 agonist or 2.5 mg of nebulized levalbuterol, or albuterol 5.0 mg within 4 hours prior to ED or physician's office admittance.
- •Subject received ipratropium within 4 hours prior to ED or physician's office admittance.
- •Subject who participated in an investigational drug study within 30 days prior to enrollment, or who previously participated in the current study.
- •Subject with a known sensitivity to levalbuterol or racemic albuterol or any of the excipients contained in any of these formulations.
- •Subject using any prescription drug (including beta-blockers) with which levalbuterol or racemic albuterol sulfate administration is contraindicated.
- •Subject with a history of clinically significant abnormalities that could interfere with the metabolism or excretion of the study medication (eg, renal, hepatic, metabolic, or endocrine abnormalities).
- •Subject with a history of cancer.
研究组 & 干预措施
levalbuterol tartrate HFA inhalation aerosol plus placebo HFA
Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol
干预措施: levalbuterol tartrate HFA inhalation aerosol (Drug)
levalbuterol tartrate HFA inhalation aerosol plus placebo HFA
Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol
干预措施: placebo (Drug)
levalbuterol tartrate HFA inhalation aerosol plus levalbuterol
Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.
干预措施: levalbuterol tartrate HFA inhalation aerosol (Drug)
结局指标
主要结局
The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events.
时间窗: Week 1
Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.
The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Serious Adverse Events.
时间窗: Week 1
Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.
The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events Leading to Discontinuation.
时间窗: Week 1
Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.
次要结局
- Change From Baseline in Pulmonary Score (Total Score) to End of Treatment(Day 1)
- Change From Baseline in Pulmonary Score (Individual Component Scores) to End of Treatment(Day 1)
- Change From Baseline in Pulmonary Score (Total Score) After Each Dose(20 minutes, 40 minutes, 60 minutes)
- Change From Baseline in Pulmonary Score (Individual Component Scores) After Each Dose(20 minutes, 40 minutes, 60 minutes)
- Number and Percentage of Subjects Determined to be Stabilized After Treatment(Day 1)