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fluticasone

Phase 3

Rhinitis Allergic | Small molecule | Other |Sanofi|Last Updated: Apr 25, 2022

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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment260
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03317015A Study to Assess Efficacy and Safety of Nasacort® Nasal Spray in Comparison With Flixonase® Nasal Spray in Adults Suffering From Perennial Allergic Rhinitis (PAR)PHASE3 COMPLETED 260Nov 30, 2016Jul 10, 2017Apr 25, 2022 -
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Study Endpoints
Primary Endpoints
Change from baseline in total nasal symptom score
From baseline (0 day of treatment) to 28th day of treatment
Secondary Endpoints
Change from baseline in quality of life questionnaire scores (miniRQLQ questionnaire)
From baseline (0 day of treatment) to 28th day of treatment
Number of participants with adverse events
From baseline (0 day of treatment) to 28th day of treatment
Assessment of patient satisfaction using the 5-point scale questionnaire
28th day of treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group A - Nasacort®EXPERIMENTALNasacort® will be sprayed twice in each nostril once every morning
Group B - Flixonase®ACTIVE_COMPARATORFlixonase® will be sprayed twice in each nostril once every morning
Interventions
NameTypeDescription
triamcinolone XRG5029DRUGPharmaceutical form: spray solution Route of administration: nasal
fluticasoneDRUGPharmaceutical form: spray solution Route of administration: nasal
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersNo

Inclusion criteria: * Females and males ≥18 and ≤50 years old. * Patients with previously diagnosed PAR with a positive skin prick test response to an appropriate allergen performed not earlier than 12 months prior to the Screening visit. * Patients must be clinically symptomatic (rTNSS reflecting ...

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