The Addition of Vitamin D to Fluticasone Propionate in the Management of Seasonal Allergic Rhinitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period
研究概览
简要总结
The objectives of this study would be to see if the addition of vitamin D to fluticasone propionate provides greater symptomatic relief in patients with seasonal allergic rhinitis compared to fluticasone propionate treatment alone.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Fluticasone Propionate plus Vitamin D3
Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season
干预措施: Vitamin D3 (Drug)
Fluticasone Propionate plus Vitamin D3
Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season
干预措施: Fluticasone Propionate (Drug)
Fluticasone Propionate plus Placebo
Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season
干预措施: Placebo (Drug)
Fluticasone Propionate plus Placebo
Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season
干预措施: Fluticasone Propionate (Drug)
结局指标
主要结局
Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period
时间窗: Baseline and 2 weeks
Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The TNSS was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 24. The change from baseline for each day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms.
次要结局
- Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period(Baseline and 2 weeks)