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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: FLOVENT (fluticasone propionate) HFA (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline


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.

Clinical Details

Official title: See Detailed Description

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Serum cortisol weighted mean(0-12h)

Secondary outcome: Serum cortisol Cmin FP Cmaxss, AUClast and tmaxss Adverse events

Detailed description: 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


Minimum age: 6 Months. Maximum age: 12 Months. Gender(s): Both.


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

Locations and Contacts

GSK Investigational Site, Huntington Beach, California 92647, United States

GSK Investigational Site, Centennial, Colorado 80112, United States

GSK Investigational Site, Jacksonville, Florida 32207, United States

GSK Investigational Site, Atlanta, Georgia 30309-7520, United States

GSK Investigational Site, Normal, Illinois 61761, United States

GSK Investigational Site, Oklahoma City, Oklahoma 73112, United States

GSK Investigational Site, Dallas, Texas 75230, United States

Additional Information

Starting date: August 2006
Last updated: May 15, 2009

Page last updated: August 20, 2015

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