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

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ClinicalTrials.gov Identifier: NCT00370097

Recruitment Status : Completed

First Posted : August 30, 2006

Last Update Posted : September 11, 2017

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Asthma	Drug: FLOVENT (fluticasone propionate) HFA Drug: Placebo HFA	Phase 1

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

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	16 participants
Allocation:	Non-Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	PD of Hydrofluoroalkane Propellant of Inhaled Fluticasone Propionate Following Administration in Pediatric Subjects 6-12 Months of Age With Asthma
Actual Study Start Date :	August 30, 2006
Actual Primary Completion Date :	April 12, 2007
Actual Study Completion Date :	April 12, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Fluticasone Fluticasone furoate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Subjects receiving HFA Subjects in Session 1 will receive two inhalations of placebo HFA by meter-dose inhaler (MDI) twice daily and in Session 2 subjects will receive two inhalations of fluticasone propionate (FP) HFA MDI 44 mcg twice daily	Drug: FLOVENT (fluticasone propionate) HFA FLOVENT HFA consists of a white to off-white suspension of FP (micronized) in a liquefied hydrofluoroalkane propellant, 1,1,1,2-tetrafluoroethane. Subject will receive FP HFA using an Aerochamber Plus with Infant Mask. Drug: Placebo HFA Subjects will receive FP-matched placebo using an Aerochamber Plus with Infant Mask.

Outcome Measures

Primary Outcome Measures :

Serum cortisol weighted mean(0-12h) [ Time Frame: throughout the study ]

Secondary Outcome Measures :

Serum cortisol Cmin FP Cmaxss, AUClast and tmaxss Adverse events [ Time Frame: throughout the study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	6 Months to 12 Months (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370097

Locations


United States, California
GSK Investigational Site
Huntington Beach, California, United States, 92647
United States, Colorado
GSK Investigational Site
Centennial, Colorado, United States, 80112
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32207
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30309-7520
United States, Illinois
GSK Investigational Site
Normal, Illinois, United States, 61761
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75230

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

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