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

Completed · Phase 1 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00370097

Run by

GlaxoSmithKline

People needed

16

Starts

2006-08-30

Expected to finish

2007-04-12

Last updated by the study team

2017-09-11

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Huntington Beach, California, United States
• GSK Investigational Site — Centennial, Colorado, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Normal, Illinois, United States
• GSK Investigational Site — Oklahoma City, Oklahoma, United States
• GSK Investigational Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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