NCT00361439终止4 期
Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Histological Findings
研究概览
简要总结
People with allergies frequently complain of a loss or reduction in the sense of smell.
In this study, the investigators propose to perform a randomized, double blind, placebo controlled parallel study of subjects with nasal allergies and decreased smell to determine the effect of a treatment for allergies on the sense of smell.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females between 18 and 59 years of age.
- •Seasonal allergic rhinitis by clinical history, with symptoms of impaired olfaction.
- •Positive skin or RAST test to allergen.
- •Symptoms of olfactory dysfunction.
- •No significant history of chronic sinusitis.
排除标准
- •Women of childbearing potential not using the contraception method(s) (Birth control pills, depo Provera, double barrier) as well as women who are breastfeeding.
- •Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease).
- •Use of any other investigational agent in the last 30 days.
- •Absence of olfactory or nasal symptoms.
- •Use of medications that may affect olfaction.
- •Medical conditions that may affect olfaction.
- •URI at the time of screening.
研究组 & 干预措施
Mometasone
Active Comparator
Mometasone intranasal steroid therapy daily for 2 weeks
干预措施: Mometasone (Drug)
Placebo
Placebo Comparator
2 puffs of placebo spray in each nostril once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Histological Findings
时间窗: 2 weeks
Number of eosinophils per high-powered field (HPF) in olfactory biopsy taken after 2 weeks of study treatment (higher values indicate greater inflammation); average of three HPF reported
次要结局
- Change From Baseline in Total Nasal Symptom Score at 2 Weeks(baseline and 2 weeks)
- Change From Baseline in Nasal Peak Inspiratory Flow at 2 Weeks(baseline and 2 weeks)
- Change From Baseline in Percentage of Eosinophils at 2 Weeks(baseline and 2 weeks)
研究者
研究点 (1)
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