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

Study Overview
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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.

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

Official Title
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PD of Hydrofluoroalkane Propellant of Inhaled Fluticasone Propionate Following Administration in Pediatric Subjects 6-12 Months of Age With Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: FLOVENT (fluticasone propionate) HFA
* Drug: Placebo HFA


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects receiving HFA<br>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<br>* 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.<br>Drug: Placebo HFA<br>* Subjects will receive FP-matched placebo using an Aerochamber Plus with Infant Mask.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum cortisol weighted mean(0-12h) |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum cortisol Cmin FP Cmaxss, AUClast and tmaxss Adverse events |  | throughout the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma infants FLOVENT spacer