PD of Hydrofluoroalkane Propellant of Inhaled Fluticasone Propionate Following Administration in Pediatric Subjects 6-12 Months of Age With Asthma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Serum cortisol weighted mean(0-12h)
研究概览
简要总结
The purpose of this study is to address an Food Drug and Administration (FDA) request to provide safety data in pre-asthmatic patients, ages 6 months to <12 months, following administration of fluticasone propionate HFA.
详细描述
A repeat-dose, open-label, 2-session study to assess the systemic exposure to, and pharmacodynamics of, fluticasone propionate HFA inhalation aerosol 88mcg administered twice-daily for 28 days delivered via an MDI and valved holding chamber with infant facemask to subjects ages 6 months to <12 months who have experienced 2 or more wheezing episodes in the preceding 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have experienced 2 or more wheezing episodes in the previous 6 months.
- •Subjects may not have taken any corticosteroids in the 4 weeks prior to dosing
- •Parents/guardians should be able to read and comprehend diary information collected throughout the study
- •Parents must be able to demonstrate the ability to use the facemask and spacer used to administer study drug
- •Exclusion criteria:
- •Subjects who weigh less than 7 kg
- •Subjects who are taking any drugs that inhibit or induce the cytochrome P450 isoform
- •Any parents who have a history of psychiatric disease, intellectual deficiency, substance abuse that would compromise the validity of the consent
排除标准
- 未提供
研究组 & 干预措施
Subjects receiving HFA
Subjects in Session 1 will receive two inhalations of placebo HFA by meter-dose inhaler (MDI) twice daily and in Session 2 subjects will receive two inhalations of fluticasone propionate (FP) HFA MDI 44 mcg twice daily
干预措施: FLOVENT (fluticasone propionate) HFA (Drug)
Subjects receiving HFA
Subjects in Session 1 will receive two inhalations of placebo HFA by meter-dose inhaler (MDI) twice daily and in Session 2 subjects will receive two inhalations of fluticasone propionate (FP) HFA MDI 44 mcg twice daily
干预措施: Placebo HFA (Drug)
结局指标
主要结局
Serum cortisol weighted mean(0-12h)
时间窗: throughout the study
次要结局
- Serum cortisol Cmin FP Cmaxss, AUClast and tmaxss Adverse events(throughout the study)