Comparison of the Effect of Fluticasone Furoate Nasal Spray Versus Placebo on Allergic Mediators in the Tears of Subjects With Tree or Grass Pollen Allergy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Eosinophilic Cationic Protein (ECP) Levels
研究概览
简要总结
Rationale and objectives:
Fluticasone furoate nasal spray (Veramyst) has been shown to improve ocular symptoms when used for the treatment of seasonal allergic rhinitis during the ragweed pollen season. Although this is the only published report of an intranasal corticosteroid shown to effectively treat ocular symptoms, the mechanism has not been delineated. Furthermore, the tears of patients with allergic conjunctivitis are known to have increased concentrations of cytokines and allergic mediators.
The objective of this study is to determine if the positive effects of Veramyst nasal spray on ocular symptoms is via the inhibition of allergic mediators in the eyes. The investigators will conduct a double blind placebo controlled trial to determine if Veramyst nasal spray decreases the amount of allergic mediators in the tears of subjects randomized to Veramyst nasal spray versus placebo. The investigators will also compare the subjects' symptoms to the amount of allergic mediators detected in their tears.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a documented history of allergic rhinitis and conjunctivitis due to tree pollen and / or grass pollen for two allergy seasons
- •positive skin prick test to tree and / or grass
排除标准
- •cataracts
- •acute or chronic sinusitis
- •chronic obstructive pulmonary disease
- •physical nasal obstruction
- •pregnant or breastfeeding
- •have had a viral or bacterial infections within 2 weeks of the study commencement
- •receiving allergen immunotherapy
- •have used inhaled corticosteroids within 14 days prior to the study
- •have used systemic corticosteroids within 30 days of the study
- •travel outside of the geographic area during the 2 week study period
- •use of contact lenses during the study period
- •use of artificial tears during the study period
- •use of eyewash irrigation during the study period
- •use of lubricants during the study period
研究组 & 干预措施
Placebo nasal spray
干预措施: Placebo nasal spray (Drug)
Fluticasone furoate nasal spray
干预措施: Fluticasone furoate nasal spray (Drug)
结局指标
主要结局
Eosinophilic Cationic Protein (ECP) Levels
时间窗: Samples taken at initial visit & 2 week follow-up
Tear samples from the participants eyes were collect and were to be used for measuring esinophilic cationic prtein, but this was not measured because the volume of tears were to low.
次要结局
- Histamine Content in the Tears Was Measured.(Samples taken at initial visit & 2 week follow-up)
研究者
James Moy
MD
Rush University Medical Center