A repeat-dose, open-label, 2-session study to assess the systemic exposure to, and pharmacodynamics of, fluticasone propionate HFA inhalation aerosol 88 mcg administered twice-daily for 28 days delivered via an MDI and valved holding chamber with infant face mask to subjects ages 6 months to <12 months who have experienced 2 or more wheezing episodes in the preceding 6 months.

GlaxoSmithKline Research & Development0 个研究点目标入组 16 人开始时间: 2016年12月21日最近更新: 2017年1月9日

研究概览

暂无简介。

•- 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
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 16
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- 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

发起方