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)

Phase 3

Completed

• Conditions: Rhinitis Allergic
• Interventions: Drug: triamcinolone XRG5029; Drug: fluticasone

• Registration Number: NCT03317015
• Lead Sponsor: Sanofi

Brief 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.

Study Timeline

• Study Start: 2016-11-30
• Primary Completion: 2017-07-10
• Study Completion: 2017-07-10
• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-18
• Study First Posted: 2017-10-23
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-22
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A - Nasacort®	triamcinolone XRG5029	Nasacort® will be sprayed twice in each nostril once every morning
Group B - Flixonase®	fluticasone	Flixonase® will be sprayed twice in each nostril once every morning

Primary Outcome Measures

Name	Time	Method
Change from baseline in total nasal symptom score	From baseline (0 day of treatment) to 28th day of treatment

Secondary Outcome Measures

Name	Time	Method
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
Change from baseline in quality of life questionnaire scores (miniRQLQ questionnaire)	From baseline (0 day of treatment) to 28th day of treatment
Assessment of physician satisfaction using the 5-point scale questionnaire	28th day of treatment