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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00370097

Enrollment

Registered

2006-08-30

Start date

2006-08-30

Completion date

2007-04-12

Last updated

2017-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma infants FLOVENT spacer

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

Interventions

DRUGPlacebo HFA

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

DRUGFLOVENT (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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 12 Months

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

Design outcomes

Primary

Measure	Time frame
Serum cortisol weighted mean(0-12h)	throughout the study

Secondary

Measure	Time frame
Serum cortisol Cmin FP Cmaxss, AUClast and tmaxss Adverse events	throughout the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026