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

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: FLOVENT (fluticasone propionate) HFA; Drug: Placebo HFA

• Registration Number: NCT00370097
• Lead Sponsor: GlaxoSmithKline

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.

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 Timeline

• Study First Submitted: 2006-08-28
• Study First Submitted QC: 2006-08-28
• Study Start: 2006-08-30
• Study First Posted: 2006-08-30
• Primary Completion: 2007-04-12
• Study Completion: 2007-04-12
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-07
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Subjects receiving HFA	Placebo 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
Subjects receiving HFA	FLOVENT (fluticasone propionate) 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

Primary Outcome Measures

Name	Time	Method
Serum cortisol weighted mean(0-12h)	throughout the study

Secondary Outcome Measures

Name	Time	Method
Serum cortisol Cmin FP Cmaxss, AUClast and tmaxss Adverse events	throughout the study

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Dallas, Texas, United States