Asthma Clinical Trial
Official title:
A Randomised, Open-Label, Four Period, Crossover Study to Assess the Systemic Exposure of Fluticasone Propionate From FLIXOTIDE™ 250 HFA pMDI and of Fluticasone Propionate and Salmeterol From SERETIDE™ 250/25 HFA pMDI When Given With the VENTOLIN Mini-Spacer Compared to the Aerochamber Plus Spacer in Healthy Subjects
The VENTOLIN Mini-Spacer is being developed in order to support patients in the Emerging
Markets and Asia Pacific regions who do not have access to affordable spacers. The aim of
this exploratory study is to investigate whether the systemic exposure for fluticasone
propionate (FP) and salmeterol observed with the VENTOLIN Mini-Spacer is comparable to the
systemic exposure for FP and salmeterol observed with the Trudell Aerochamber Plus spacer for
both FLIXOTIDE and SERETIDE Metered Dose Inhaler (MDI) products. There will be four study
periods in the study and all participants will receive four study treatments during the
study. The total duration of study including screening, treatment period, washout period, and
follow-up period will be 58 days. Study is planned to enroll 20 healthy subjects.
VENTOLIN is a registered trademark of GlaxoSmithKline. FLIXOTIDE is a registered trademark of
GlaxoSmithKline. SERETIDE is a registered trademark of GlaxoSmithKline.
n/a
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