A Double Blind, Placebo Controlled Randomized Trial Evaluating the Effects of Fluticasone Nasal Spray in Subjects With Seasonal Allergic Rhinitis and a History of Sleep Disturbance on Cognitive Performance and Daytime Sleepiness
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Response Time for Targets.
研究概览
简要总结
The hypothesis is that treating hay fever patients who had daytime sleepiness and slowed thinking because of the hay fever will improve when treated with an effective anti-hay fever medication, an intranasal steroid, that is will have less daytime sleepiness and demonstrate better thinking.
详细描述
In this study of patients with seasonal allergic rhinitis we will monitor daytime sleepiness as measured by validated daytime sleep score (Eppworth Daytime Sleepiness Scale) and cognitive performance weekly as measured by a validated test of cognitive performance (TOVA). The treatment group with intervention of fluticasone furoate nasal spray 110 mcg two sprays in each nostril once daily will be compared to a placebo treated group of similar subjects with seasonal allergic rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptomatic seasonal allergic rhinitis symptoms for at least 2 years at the time of study in the season of the study.
- •Allergy skin tests positive for the airborne allergens present at the study time within the past 12 months.
- •A score of 2 or more on the NRQLQ of the Rhinitis Quality of LIfe Questionnaire.
- •Active allergic rhinitis on 4 of 7 days during run-in week, and evidence on sleep scales of drowsiness on 3 of 7 days.
- •Ability to read, understand and give informed consent.
- •Ability to understand and carry out responsibilities of the study
排除标准
- •Any chronic disease or other acute disease, which could influence central nervous system.
- •The use of any medication, which could affect central nervous system function.
- •Unwillingness to participate in the study.
- •Inability to understand testing procedures or use of medication.
- •Hypersensitivity to fluticasone or vehicle of nasal sprays.
- •Any sleep disorders including obstructive sleep apnea.
研究组 & 干预措施
Placebo
Placebo treatment given as a once daily dose intranasally.in subjects with active seasonal allergic rhinitis.
干预措施: Placebo (Drug)
Fluticasone Furoate
IFluticasone Furoate 110 mcg given intranasly once daily in am as an active treatment of seasonal allergic rhinitis
干预措施: Fluticasone furoate Nasal Spray 110 mcg (Drug)
结局指标
主要结局
Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Response Time for Targets.
时间窗: over 2 weeks
The outcomes measures for TOVA are the length of time to respond to targets. The time function represents the average time spent in milliseconds spent on each target.
Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance
时间窗: over 2 weeks
The outcomes measures for TOVA are errors of omission. Targets which were not identified. Errors of commission are when targets are identified incorrectly. Reaction time is reported as the average time in milliseconds for the responses. The results are reported as mean and standard deviation as baseline and after 2 weeks of intervention. The difference between the means was evaluated by paired t testing.
Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Errors of Commission.
时间窗: after 2 weeks intervention
The outcomes measures for TOVA are errors of commission. Targets which were identified incorrectly. Targets which are not identified, errors of omission and average time of each target viewing.
次要结局
- Change in Epworth Sleep Scale(Baseline and after 2 weeks intervention)
- Nasal Symptom Scores(2 weeks)
- Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire(2 weeks)
研究者
Lyndon Mansfield
Director
Western Sky Medical Research