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FLOVENT HFA

Phase 1

Asthma | Small molecule | Respiratory |GSK plc|Last Updated: Sep 11, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

FLOVENT HFA · 1 trial · 1 indication

Phase 1 1
NCT00370097FLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old SubjectsAsthma
COMPLETED16 Analytics
PHASE1COMPLETED
FLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old Subjects
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Serum cortisol Cmin FP Cmaxss, AUClast and tmaxss Adverse events
throughout the study
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Subjects receiving HFAEXPERIMENTALSubjects 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

Interventions

NameTypeDescription
FLOVENT (fluticasone propionate) HFADRUGFLOVENT 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 HFADRUGSubjects will receive FP-matched placebo using an Aerochamber Plus with Infant Mask.
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Eligibility Criteria

Age Range6 Months to 12 Months
SexALL
Healthy VolunteersNo
Study Sites7

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 * Par...

Countries:United States
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Frequently asked questions about FLOVENT HFA

What is FLOVENT HFA used for?

FLOVENT HFA is used for asthma. It is a small molecule respiratory drug developed by GSK plc (ticker: GSK). It is currently in Phase 1 clinical development for this indication.

Who makes FLOVENT HFA?

FLOVENT HFA is developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical research on this small molecule respiratory drug for the treatment of asthma.

What phase is FLOVENT HFA in?

FLOVENT HFA is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed to evaluate its use in young children with asthma.

What clinical trials is FLOVENT HFA in?

FLOVENT HFA has one completed clinical trial, NCT00370097, titled "FLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old Subjects." This Phase 1 study enrolled 16 participants with asthma in the United States and was not randomized or blinded.

Is FLOVENT HFA the same as FLOVENT?

FLOVENT HFA is a formulation of FLOVENT that uses a hydrofluoroalkane propellant. The clinical trial NCT00370097 specifically evaluated this HFA version in subjects aged 6 to 12 months with asthma.