drugset / Trial / NCT03317015

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)

NCT03317015

Phase 3 Completed 260 enrolled Sanofi
RandomizedParallel-groupTriple-blindTreatment

Summary

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).

Timeline

Start
2016-11-30
Primary completion
2017-07-10
Completion
2017-07-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluticasone Other / unclassified 50 ug Intranasal
Subject Triamcinolone Other / unclassified 55 ug Intranasal

Indications