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OPTINOSE FLUTICASONE

Phase 1

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

Target and mechanism

ModalitySmall molecule

Also known as OPTINOSE™ FLUTICASONE

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

OPTINOSE FLUTICASONE · 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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