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Flovent HFA

Phase 1

Mild to Moderate Asthma | Small molecule | Respiratory |OptiNose, Inc.|Last Updated: Feb 3, 2016

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

Flovent HFA · 1 trial · 1 indication

Phase 1 1
NCT02266927A Study to Compare the Bioavailability Intranasal Administration of 200 and 400 µg or 400 µg Alone of OPTINOSE™ FLUTICASONE With 440 µg of Flovent® HFA (Fluticasone Propionate) Inhalation Aerosol (Part 2)Mild to Moderate Asthma
COMPLETED28 Analytics
PHASE1COMPLETED
A Study to Compare the Bioavailability Intranasal Administration of 200 and 400 µg or 400 µg Alone of OPTINOSE™ FLUTICASONE With 440 µg of Flovent® HFA (Fluticasone Propionate) Inhalation Aerosol (Part 2)
Mild to Moderate Asthma
NCT0226692728
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Study Endpoints

Primary Endpoints

The ratio of least-squares means of the ln transformed PK parameter AUC0-∞ is the primary endpoint.
Pre-dose and at 0.167, 0.333, 0.5, 0.75, 1, 1.333, 1.667, 2, 2.5, 3, 4, 6, 9, 12, 16, 24, and 36 hours after dosing

Part 2

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Flovent® HFA 440µgACTIVE_COMPARATORFlovent® HFA (fluticasone propionate) Inhalation Aerosol 440 µg
OPTINOSE™ FLUTICASONE 400µg intranasalEXPERIMENTALOPTINOSE™ FLUTICASONE, single dose of 400 µg intranasally

Interventions

NameTypeDescription
Flovent HFADRUG -
OPTINOSE™ FLUTICASONEDRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Male or female subjects' ages 18 to 55 years, inclusive, at screening. 2. Have a body mass index of 18 to 32 kg/m2, inclusive, and a body weight of not less than 52 kg for males and 45 kg for females. 3. Otherwise healthy mild to moderate asthmatic (Part 2) with no clinically...

Countries:Ireland
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Frequently asked questions about Flovent HFA

What is Flovent HFA used for?

Flovent HFA is a fluticasone propionate inhalation aerosol being studied for use in mild to moderate asthma. It is an investigational drug in clinical development and is not approved for this use. The drug is being evaluated in a Phase 1 clinical trial.

Who makes Flovent HFA?

Flovent HFA is being developed by OptiNose, Inc., a company traded on the NASDAQ under the ticker symbol OPTN. The company is conducting clinical research on this fluticasone propionate inhalation aerosol for mild to moderate 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. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development for mild to moderate asthma.

What clinical trials is Flovent HFA in?

Flovent HFA has one completed Phase 1 clinical trial, NCT02266927, which enrolled 28 participants with mild to moderate asthma in Ireland. The study compared the bioavailability of intranasal fluticasone at 200 and 400 µg or 400 µg alone with 440 µg of Flovent HFA inhalation aerosol.

How does Flovent HFA work?

Flovent HFA contains fluticasone propionate, a corticosteroid that works by reducing inflammation in the airways. It is administered as an inhalation aerosol. The drug is being studied for its bioavailability and effects in patients with mild to moderate asthma.