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Triamcinolone

Phase 4

Rhinitis, Allergic, Perennial | Small molecule | Respiratory |Sanofi|Trials Updated: Jan 11, 2011

Triamcinolone development status

Highest phase Phase 4 run by University of Oxford (NCT03797872)
Phase scored for SNYPhase 3
Registered trials 5 across 4 sponsors since Aug 2005

Triamcinolone target and mechanism

Molecular targetNR3C1
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment460

FDA Designations

No designations recorded

Triamcinolone clinical trials

Triamcinolone · 1 trial · 1 indication

Phase 3 1
NCT00132925An Efficacy and Safety Evaluation of Nasacort AQ in Children Ages 2-5 Years With Perennial Allergic RhinitisRhinitis, Allergic, Perennial
COMPLETED460 Analytics
PHASE3COMPLETED
An Efficacy and Safety Evaluation of Nasacort AQ in Children Ages 2-5 Years With Perennial Allergic Rhinitis
Rhinitis, Allergic, PerennialUnlock trial analytics

Study Endpoints

Primary Endpoints

Double-blind phase: Change from baseline in mean daily instantaneous (immediately prior to dosing) Total Nasal Symptom Score (TNSS) over the 4-week double-blind period
Open-label phase: The efficacy variable is the global evaluation of efficacy as rated by the physician and the subject

Secondary Endpoints

Change from baseline: in mean daily reflective (previous 24 hours) TNSS over 4-wk double-blind period
for mean daily instantaneous and reflective TNSS by week
for mean instantaneous and reflective daily scores for nasal stuffiness, nasal discharge, sneezing, nasal itching, and total eye symptoms by week and over four week double-blind period
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
TriamcinoloneDRUG -
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Eligibility Criteria

Age Range2 Years to 5 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects will be male or female children ages 2-5 years with a history of at least 1 year of perennial allergic rhinitis (PAR) with or without seasonal allergic rhinitis (SAR) characterized by nasal stuffiness, nasal discharge, sneezing, nasal itching, and total eye symptoms, ...

Countries:United States
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Frequently asked questions about Triamcinolone

What is Triamcinolone used for in perennial allergic rhinitis?

Triamcinolone is a small molecule developed by Sanofi for the treatment of perennial allergic rhinitis, a year-round allergic nasal condition. It is being studied in a Phase 3 clinical program, including a completed trial in children ages 2 to 5 years with this indication.

What does Triamcinolone target?

Triamcinolone targets NR3C1, the glucocorticoid receptor, and acts as an agonist at this receptor. By binding and activating NR3C1, it produces glucocorticoid effects relevant to controlling allergic inflammation in perennial allergic rhinitis.

Who makes Triamcinolone?

Sanofi is the developer of Triamcinolone, traded under the ticker SNY. The company is advancing the small molecule through clinical development for perennial allergic rhinitis.

What phase is Triamcinolone in?

Triamcinolone is in Phase 3 development for perennial allergic rhinitis. It is an investigational therapy and is not approved based on the development information available. The Phase 3 program includes one completed trial with 460 enrolled participants.

What clinical trials is Triamcinolone in?

Triamcinolone has been evaluated in the Phase 3 trial NCT00132925, titled an efficacy and safety evaluation of Nasacort AQ in children ages 2 to 5 years with perennial allergic rhinitis. The trial enrolled 460 participants in the United States and is completed.

Is Triamcinolone the same as Nasacort AQ?

Nasacort AQ is a nasal spray formulation of Triamcinolone. The Phase 3 trial NCT00132925 evaluated Nasacort AQ in children ages 2 to 5 years with perennial allergic rhinitis, so references to Nasacort AQ in this program describe the same active drug.