Recent Updates
Recently added Catalysts

FLOVENT HFA

Phase 3FDA approved 2004

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

FLOVENT HFA development status

FDA approval May 14, 2004
Approval holderGlaxo Grp Ltd
ApplicationNDA021433
Highest phase Phase 3 run by Teva Branded Pharmaceutical Products R&D, Inc. (NCT02175771)
Phase scored for GSKPhase 1
Registered trials 2 across 2 sponsors since Jun 2014

Label indication Fluticasone Propionate HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older. Limitations of Use Fluticasone Propionate HFA is not indicated for the relief of acute bronchospasm. FDA label

FLOVENT HFA target and mechanism

ModalitySmall molecule

Also known as FLOVENT (fluticasone propionate) HFA

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

FLOVENT HFA clinical trials

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
Unlock Study Endpoints

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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about FLOVENT HFA

What is FLOVENT HFA used for?

FLOVENT HFA is used for asthma. It is an inhaled small molecule therapy developed by GSK plc, traded as GSK, and studied in a Phase 1 trial in the United States. The trial enrolled 16 subjects aged 6 to 12 months with asthma.

Who makes FLOVENT HFA?

FLOVENT HFA is made by GSK plc, which trades under the ticker GSK. GSK developed and studied the drug in a Phase 1 clinical trial in the United States. The trial, NCT00370097, was completed and enrolled 16 subjects.

What phase is FLOVENT HFA in?

FLOVENT HFA is in Phase 1 clinical development. Its single trial, NCT00370097, was a completed Phase 1 study in the United States that enrolled 16 subjects aged 6 to 12 months with asthma. No active trials are ongoing.

What clinical trials is FLOVENT HFA in?

FLOVENT HFA has been studied in one clinical trial, NCT00370097, titled FLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old Subjects. The Phase 1 trial was completed, enrolled 16 subjects with asthma, and took place in the United States.

Is FLOVENT HFA the same as FLOVENT (fluticasone propionate) HFA?

Yes, FLOVENT HFA is also known as FLOVENT (fluticasone propionate) HFA. Both names refer to the same inhaled asthma therapy developed by GSK plc, ticker GSK, which was studied in the completed Phase 1 trial NCT00370097.