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NCT03317015: NASANIF

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)

Completed Phase 3 Last updated 25 April 2022
What this trial tests

Phase 3 trial testing triamcinolone XRG5029 in Rhinitis Allergic in 260 participants. Completed in 10 July 2017.

Timeline
30 November 2016
Primary endpoint
10 July 2017
10 July 2017

Quick facts

Lead sponsorSanofi
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment260
Start date30 November 2016
Primary completion10 July 2017
Estimated completion10 July 2017

Drugs / interventions tested

Conditions studied

Sponsor

Sanofi — full company profile →

Who can join

Adults 18 to 50, any sex, with Rhinitis Allergic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary Objective: * To assess efficacy of Nasacort® (triamcinolone) nasal spray, 55 µg per dose, in comparison with Flixonase® (fluticasone) nasal spray, 50 µg per dose, by reflective total nasal symptom score (rTNSS) (24 h) after 28 days of treatment compared with baseline (0 day of treatment) in adult patients suffering from PAR (perennial allergic rhinitis). Secondary Objectives: * To evaluate safety of Nasacort® (triamcinolone) nasal spray, in comparison with Flixonase® (fluticasone) administered for 28 days by assessment of adverse events reports. * To evaluate patient and physician satisfaction after 28 days of treatment by 5-point scale. * To estimate improvement of quality of life during the study by mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Triamcinolone Acetonide versus Fluticasone Propionate in the Treatment of Perennial Allergic Rhinitis: A Randomized, Parallel-Group Trial.
    Karaulov AV, Vylegzhanina T, Ovchinnikov A, Chernikova M, et al · · 2019 · cited 8× · PMID 30879006 · DOI 10.1159/000497160
  2. Triamcinolone Acetonide in the Treatment of Perennial Allergic Rhinitis: A post hoc Analysis of Quality of Life during a Phase III Study.
    Karaulov AV, Nenasheva N, Smolkin Y, Maslakov A, et al · · 2022 · cited 3× · PMID 34515149 · DOI 10.1159/000518753
  3. Triamcinolone Acetonide in the Treatment of Perennial Allergic Rhinitis: A post hoc Efficacy Analysis of a Phase III Study Performed in Russia.
    Karaulov AV, Ilina NI, Shartanova N, Maslakov A, et al · · 2022 · cited 2× · PMID 34535609 · DOI 10.1159/000518754

Verify or expand the search:

Other recruiting trials for Rhinitis Allergic

Currently open trials in the same condition.

Other Sanofi trials

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03317015.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing