FLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old Subjects

• Status: Completed
• Trial end date: 2007-04-12
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluticasone; Xhance

Criteria

Inclusion Criteria:

• 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