Corn Based Occupational Rhinitis; SCIT Efficacy Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Corn based Occupational Rhinitis symptom and medication score surveys
研究概览
简要总结
Patients demonstrated allergic to corn pollen and timothy grass pollen (by allergy testing) who have undergone 1 to 2 years of subcutaneous allergen immunotherapy (SCIT) containing timothy grass extract with moderate symptomology (as documented via rhinitis symptom score surveys) will constitute the treatment group. Those who previously chose not to undergo SCIT who have documented symptomology and are skin test positive to corn pollen will constitute the control group. Prospective symptom score analyses and retrospective quality of life assessments (RQLQ) will be the primary and secondary efficacy outcome measures.
详细描述
Statistical assessment suggests enrollment of 20 patients into the treatment group (defined above) and an additional 20 into the control group. Patients will be matched for the level of symptomology (based on symptom score surveys) and residing/working on corn-crop farms. The premise for this study is the cross-reactivity of putative immunogenic sites between timothy grass pollen and corn pollen. based on consensus genetic sequences. Thus, the hypothesis is the use of Timothy grass extract containing immunotherapy would diminish symptomology to corn-based occupational rhinitis. Enrolled patients will have signed IRB approved consent forms and have undergone SCIT for 1 to 2 plus years (treatment group) or not undergone SCIT therapy for the same time period (control group). Potential contribution to symptom scores from other sources (e.g. Ragweed) will be analyzed by assessment of local pollen counts.Efficacy assessment will compare prospective symptom score results and retrospective quality of life survey scores between the treatment and control group responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Negative allergy test to corn pollen,
- •Not residing on/near farm growing corn,
- •An initial symptom score of < 9.
结局指标
主要结局
Corn based Occupational Rhinitis symptom and medication score surveys
时间窗: prior to study enrollment patients completed more than 1 year of SCIT. Actual study is 1 day to complete surveys.
The completed symptom and medication score surveys will be contrasted from before to after therapy and between treatment and control groups.
次要结局
- Corn based Occupational Rhinitis quality of life surveys(Actual survey completions take less than 1 day.)