临床试验/NCT03317015

NCT03317015已完成3 期

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

Sanofi0 个研究点目标入组 260 人开始时间: 2016年11月30日最近更新: 2022年4月25日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Sanofi
入组人数: 260
主要终点: Change from baseline in total nasal symptom score

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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).

详细描述

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

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 18 Years 至 50 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

Group A - Nasacort®

Experimental

Nasacort® will be sprayed twice in each nostril once every morning

干预措施: triamcinolone XRG5029 (Drug)

Group B - Flixonase®

Active Comparator

Flixonase® will be sprayed twice in each nostril once every morning

干预措施: fluticasone (Drug)

结局指标

主要结局

Change from baseline in total nasal symptom score

时间窗: From baseline (0 day of treatment) to 28th day of treatment

次要结局

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)

研究者

发起方

Sanofi

申办方类型

Industry

责任方

Sponsor

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