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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Placebo HFA; Drug: FLOVENT (fluticasone propionate) HFA

Study type: Interventional

Funder types: Industry

Identifiers

NCT00370097

FAS106533

Details and patient eligibility

About

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.

Full 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

Enrollment: 16 patients

Sex: All

Ages: 6 to 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Subjects receiving HFA

Experimental group

Description:

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

Treatment:

Drug: Placebo HFA

Drug: FLOVENT (fluticasone propionate) HFA