A Cumulative Dose Safety and Tolerability Crossover Study of Arformoterol Tartrate Inhalation Solution and Levalbuterol Hydrochloride Inhalation Solution in Pediatric Subjects (Aged 2 to 11 Years of Age) With Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 主要终点
- Mean Heart Rate
研究概览
简要总结
To determine the safety and tolerability of Arformoterol Tartrate in children with asthma
详细描述
A randomized, double-blind two-way crossover study of three cumulative doses of arformoterol (7.5 ug per nebulization) and levalbuterol (0.63 mg per nebulization) given over a one hour period, followed by a single open-label treatment day with three cumulative doses of arformoterol 15 ug in subjects 2-11 years of age with asthma. 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
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female
- •Between Age 2 and 11, inclusive, at the time of consent
- •Weight equal to or greater than 15 Kg
- •History of physician-diagnosed asthma of at least 2 years duration for children age 6 and older, and at least 1 year duration for children 5 and younger.
排除标准
- •Female subject who is pregnant or lactating.
- •Subject who has a history of hospitalization for asthma within one year, or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial.
- •Subject with any history of life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures.
- •Subject with a history of cancer.
- •Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders.
- •Subject with a history of cigarette smoking or use of any tobacco products.
研究组 & 干预措施
ARF/LEV
Cross-over phase: one day active treatment with arformoterol 7.5 microgram per nebulization followed by a 7 day washout. Then a one day active treatment with levalbuterol 0.63 milligram per nebulization.
Open-label phase: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.
干预措施: levalbuterol (Drug)
LEV/ARF
Cross-over phase: one day active treatment with levalbuterol 0.63 milligram per nebulization followed by a 7 day washout. Then a one day active treatment with arformoterol 7.5 micrograms per nebulization.
Open-label phase: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.
干预措施: levalbuterol (Drug)
LEV/ARF
Cross-over phase: one day active treatment with levalbuterol 0.63 milligram per nebulization followed by a 7 day washout. Then a one day active treatment with arformoterol 7.5 micrograms per nebulization.
Open-label phase: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.
干预措施: arformoterol (Drug)
ARF/LEV
Cross-over phase: one day active treatment with arformoterol 7.5 microgram per nebulization followed by a 7 day washout. Then a one day active treatment with levalbuterol 0.63 milligram per nebulization.
Open-label phase: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.
干预措施: arformoterol (Drug)
结局指标
主要结局
Mean Heart Rate
时间窗: predose, various timeframes up to 5 hours post last dose
Heart rate measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).
Change From Predose in Mean Heart Rate
时间窗: predose, various timeframes up to 5 hours post last dose
Heart rate measured at various timepoints minus the heart rate at predose.
Mean Systolic Blood Pressure
时间窗: predose, various timeframes up to 5 hours post last dose
Systolic blood pressure measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).
Change From Predose in Mean Systolic Blood Pressure
时间窗: predose, various timeframes up to 5 hours post last dose
Mean systolic blood pressure measured at various timepoints minus the mean systolic blood pressure at predose
Mean Diastolic Blood Pressure
时间窗: predose, various timeframes up to 5 hours post last dose
Diastolic blood pressure measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).
Change From Predose in Mean Diastolic Blood Pressure
时间窗: predose, various timeframes up to 5 hours post last dose
Mean diastolic blood pressure measured at various timepoints minus the predose diastolic blood pressure
Mean Serum Potassium Levels
时间窗: Predose, 2 hours and 6 hours postdose 1
Change From Predose in Mean Serum Potassium
时间窗: predose, 2 and 6 hours post dose
Change in mean serum potassium at the specified timepoint minus the predose value.
Mean Serum Glucose Values
时间窗: Predose, 2 and 6 hours post dose 1
Change From Predose in Mean Serum Glucose
时间窗: predose, 2 and 6 hours post dose
Change in mean serum glucose at the specified timepoint minus the predose value.
次要结局
- Mean Forced Expiratory Volume in One Second(FEV1)(predose, various postdose times)
- Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1)(predose, various postdose timepoints)
- Mean Peak Expiratory Flow Rate (PEFR)(predose, various postdose times)
- Change From Predose in Mean Peak Expiratory Flow Rate (PEFR)(predose, various postdose times)
- Plasma Concentration of (R,R) Formoterol(predose, various postdose times)