NCT01231724撤回3 期
A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial of Topical Allstate in the Prevention of the Signs and Symptoms of the Acute Response to Nasal Allergen Challenge (CETALY0001)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of sneezes and total nasal symptom score (TNSS) (sum of nasal stuffiness, nasal discharge, and nasal itching) (scale 0-3 for each symptom; total score 0-9) are co-primary endpoints.
研究概览
简要总结
The purpose of this study is to see whether Allstate Nasal Spray when given in the nose is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between 18 and 55 years of age.
- •History of grass and/or ragweed allergic rhinitis for at least 2 years.
- •Positive skin test to grass and/or ragweed antigen within prior 12 months.
- •Positive response to screening nasal challenge.
排除标准
- •Respiratory disease other than allergic rhinitis, allergic conjunctivitis and mild asthma.
- •Use of nasal steroids, antihistamines in the last 2 weeks.
- •Upper respiratory infection, sinusitis less than 2 weeks before screening.
- •Structural nasal abnormalities or nasal polyps on examination, nasal ulcer, frequent nose bleeding, recent nasal surgery or nasal trauma (within 90 days).
- •Having poorly tolerated previous administration of allergens
- •Nasolacrimal drainage system malfunctions.
- •Participation in other investigational therapy in the last 30 days.
- •Any systemic disorder or medication interfering with the study.
- •FEV1<80% of predicted at screening for subjects with mild asthma.
- •Presence of allergic rhinitis symptoms in the screening period with TNSS >3 at baseline)
- •Undergoing allergen desensitization therapy.
- •Current smokers or recent ex-smokers.
- •Not willing to give informed consent
- •Inability to understand the nature and requirements of the study, or to comply with the study procedures.
- •Any social or medical condition that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
研究组 & 干预措施
Allstate Nasal Spray
Active Comparator
干预措施: Allstate Nasal Spray (Device)
Placebo Nasal Spray
Placebo Comparator
干预措施: Placebo Nasal Spray (Device)
结局指标
主要结局
Number of sneezes and total nasal symptom score (TNSS) (sum of nasal stuffiness, nasal discharge, and nasal itching) (scale 0-3 for each symptom; total score 0-9) are co-primary endpoints.
时间窗: 10 minutes following each nasal challenge
次要结局
未报告次要终点
研究者
Robert Naclerio
Professor
University of Chicago
研究点 (1)
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