A Single-Center, Double-Masked, Randomized, Placebo-Controlled, Parallel-Group Allergen BioCube Study Evaluating the Efficacy and Safety of Nasapaque Nasal Solution in a Population of Adult Subjects With Seasonal Allergic Rhinitis

Single-center, double-masked, randomized, placebo-controlled, parallel-group, efficacy and safety study using the Allergen BioCube (ABC).

开始日期2015-03-01

申办/合作机构

3E Therapeutics Corporation

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100 项与 Nasapaque 相关的临床结果

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100 项与 Nasapaque 相关的转化医学

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100 项与 Nasapaque 相关的专利（医药）

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项与 Nasapaque 相关的文献（医药）

Journal of Asthma and Allergy3区 · 医学

<p>Iodixanol nasal solution reduces allergic rhinoconjunctivitis signs and symptoms in Allergen BioCube<sup>®</sup>: a randomized clinical trial</p>

3区 · 医学

ArticleOA

作者: Stein, Linda ; Viirre, Erik ; Gomes, Paul J ; Lasser, Elliott C ; Abelson, Mark B ; Villafranca, J Ernest

PURPOSEAllergic rhinitis (AR) affects ~20% of the population worldwide. The objectives of this study were to evaluate the safety and efficacy of iodixanol nasal solution (Nasapaque) for AR treatment, using the Allergen BioCube^® (ABC^®), an environmental exposure unit. Iodixanol is a commonly used contrast media agent that shows efficacy on the signs and symptoms of AR.PATIENTS AND METHODSSeventy-three adult subjects with AR were randomized to iodixanol or placebo treatment in a double-masked efficacy and safety study conducted outside of ragweed pollen season. In-office treatment was administered after BioCube^® ragweed pollen exposure, and again 8 days later prior to ragweed exposure. Nasal and ocular efficacy and safety assessments were conducted before and after treatment.RESULTSIodixanol treatment resulted in statistically significantly lower total nasal symptom scores as compared to placebo at several time points post-treatment and ABC exposure. Individual nasal and ocular symptoms, notably nasal itching and ocular itching, showed evidence of lower scores in the iodixanol group. Peak nasal inspiratory flow (PNIF) improved (9%-16%) with iodixanol from baseline as compared to PNIF in the placebo group which ranged from 3% worsening to improvement of 2%. Few (9) adverse events occurred.CONCLUSIONIodixanol nasal solution demonstrated efficacy for relief of several nasal and ocular allergic rhinoconjunctivitis signs and symptoms, and was safe and well tolerated in this early Phase II exploratory trial. Further studies with iodixanol are warranted. Allergy challenge models such as the ABC provide valuable assessments of allergen exposures and drug efficacies.STUDY IDENTIFICATION NUMBERNCT02377895.

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
季节性过敏性鼻炎	临床2期	-	3E Therapeutics Corporation	2015-03-01
季节性过敏性鼻炎	临床2期	-	北京橙鑫数据科技有限公司	2015-03-01
过敏性鼻炎	临床2期	-	OraPharma, Inc.	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02377895 (Pubmed \| J Asthma Allergy) 人工标引	临床1/2期	过敏性鼻结膜炎	73	Nasapaque	(憲廠繭膚夢鹽遞膚憲膚) = Iodixanol treatment resulted in statistically significantly lower total nasal symptom scores as compared to placebo at several time points post-treatment and ABC exposure. 艱製衊淵築醖艱獵製獵 (衊觸遞願網襯鹹襯繭襯 ) 更多	积极	2019-03-01
				Placebo