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Fluticasone propionate

Phase 1

Allergic Rhinitis | Small molecule | Other |Pfizer, Inc.|Last Updated: Jun 2, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01064726A Study To Explore The Effect On Inflammatory Markers After Nasal Allergen Challenge In Subjects With Seasonal Allergic Rhinitis And The Effect Of A Single Dose Of Ibuprofen Or Fluticasone Propionate On The Allergen Response.PHASE1 COMPLETED 18Oct 1, 2009Apr 1, 2010Jun 2, 20101 United States
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Study Endpoints
Primary Endpoints
Nasal inflammatory markers
8h 45 min post dose
Acoustic rhinometry
8h 45 min post dose
Nasal symptom scores
8h 45 min post dose
Secondary Endpoints
Spirometry
8h 45 min post dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IbuprofenEXPERIMENTAL -
Fluticasone propionateEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
IbuprofenDRUG800 mg oral
Fluticasone propionateDRUG200 mcg intra-nasal
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range19 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female subjects with seasonal allergic rhinitis (out of season). * Sensitive to ragweed skin prick test and screening nasal allergen challenge. Exclusion Criteria: * Subjects with significant concomitant diseases. * Subjects with symptoms of allergic rhinitis in 2 we...

Countries:United States
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Competitive Landscape -Allergic Rhinitis 4 trials