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triamcinolone XRG5029

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment260

FDA Designations

No designations recorded

Clinical trial landscape

triamcinolone XRG5029 · 1 trial · 1 indication

Phase 3 1
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)Rhinitis Allergic
COMPLETED260 Analytics
PHASE3COMPLETED
A Study to Assess Efficacy and Safety of Nasacort® Nasal Spray in Comparison With Flixonase® Nasal Spray in Adults Suffering From Perennial Allergic Rhinitis (PAR)
Rhinitis Allergic
NCT03317015260
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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 to 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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