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)

A Randomized, Double-blind, Parallel-group, Multicenter, Phase III Prospective Non-inferiority Clinical Trial to Assess Efficacy and Safety of Nasacort® Nasal Spray (Triamcinolone, 55µg) in Comparison With Flixonase® Nasal Spray (Fluticasone, 50 µg) in Adults Suffering From PAR (Perennial Allergic Rhinitis) Administered Once a Day for 28 Days

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The total study duration per patient will be up to approximately 33 days.

Conditions

• Rhinitis Allergic

Interventions

Type	Name	Description
DRUG	triamcinolone XRG5029	Pharmaceutical form: spray solution Route of administration: nasal
DRUG	fluticasone	Pharmaceutical form: spray solution Route of administration: nasal

Timeline

• Start date: 2016-11-30
• Primary completion: 2017-07-10
• Completion: 2017-07-10
• First posted: 2017-10-23
• Last updated: 2022-04-25