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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-30

Study Completion Date

2007-04-12

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

FLOVENT (fluticasone propionate) HFA

Intervention Type DRUG

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.

Placebo HFA

Intervention Type DRUG

Subjects will receive FP-matched placebo using an Aerochamber Plus with Infant Mask.

Interventions

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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.

Intervention Type DRUG

Placebo HFA

Subjects will receive FP-matched placebo using an Aerochamber Plus with Infant Mask.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Huntington Beach, California, United States

Site Status

GSK Investigational Site

Centennial, Colorado, United States

Site Status

GSK Investigational Site

Jacksonville, Florida, United States

Site Status

GSK Investigational Site

Atlanta, Georgia, United States

Site Status

GSK Investigational Site

Normal, Illinois, United States

Site Status

GSK Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

GSK Investigational Site

Dallas, Texas, United States

Site Status

Countries

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United States

Study Documents

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