The Prevalence of Local IgE Elevation and Its Effect on Intranasal Capsaicin Therapy in the Non-allergic Rhinitis Population
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Runny Nose as Measured by the Visual Analog Scale (VAS) at Baseline
研究概览
简要总结
The purpose of this study to determine the therapeutic response of non-allergic rhinitis patients that have been subtyped as non-allergic rhinitis with local IgE elevation or non-allergic rhinopathy to intranasal capsaicin based on visual analog scale and optical rhinometry, to determine the prevalence of non-allergic rhinitis with local IgE elevation in this study's cohort of patients with non-allergic rhinitis identified by rhinitis history and negative skin testing for allergic rhinitis, and to determine the change, if any, in intranasal IgE levels after capsaicin treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic rhinitis
排除标准
- •Active smoker
- •Anatomic source of nasal symptoms
- •Chronic rhinosinusitis or other nasal infection
- •History of sinonasal malignancy
- •Pregnancy or lactation
- •Use of medication affecting nasal function (topical steroids, topical anticholinergics, oral antihistamines) in the previous 4 weeks
- •Use or abuse of nasal decongestants.
- •Positive skin prick test for allergic rhinitis
研究组 & 干预措施
Treatment
干预措施: Intranasal capsaicin (Drug)
Treatment
干预措施: topical lidocaine (Drug)
结局指标
主要结局
Runny Nose as Measured by the Visual Analog Scale (VAS) at Baseline
时间窗: baseline
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Runny Nose as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
时间窗: 4 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Runny Nose as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
时间窗: 12 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at Baseline
时间窗: baseline
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
时间窗: 4 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
时间窗: 12 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Itching as Measured by the Visual Analog Scale (VAS at Baseline
时间窗: baseline
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Itching as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
时间窗: 4 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Itching as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
时间窗: 12 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at Baseline
时间窗: baseline
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
时间窗: 4 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
时间窗: 12 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Change in Maximum Optical Density Determined Via Optical Rhinometry
时间窗: baseline, immediately post first treatment on Day 1
Optical rhinometry provides continuous measurement of blood flow in nasal vessels (via optical density measurements), which serves as an indirect assessment of nasal congestion. A greater decrease in optical density (OD) from baseline indicates less nasal blood flow and decreased congestion relative to baseline.
Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at Baseline
时间窗: baseline
Total Nasal Symptom score is measured as the sum of four symptom scores for runny nose, nasal symptoms of congestion, nasal itching and sneezing. Each symptom is scored from 0-10, with 0 being not a problem and 10 being unbearable. The Total nasal symptom score ranges from 0 - 40, the lower the score the better the outcome.
Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
时间窗: 4 weeks post treatment
Total Nasal Symptom score is measured as the sum of four symptom scores for runny nose, nasal symptoms of congestion, nasal itching and sneezing. Each symptom is scored from 0-10, with 0 being not a problem and 10 being unbearable. The Total nasal symptom score ranges from 0 - 40, the lower the score the better the outcome.
Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
时间窗: 12 weeks post treatment
Total Nasal Symptom score is measured as the sum of four symptom scores for runny nose, nasal symptoms of congestion, nasal itching and sneezing. Each symptom is scored from 0-10, with 0 being not a problem and 10 being unbearable. The Total nasal symptom score ranges from 0 - 40, the lower the score the better the outcome.
Maximum Optical Density Determined Via Optical Rhinometry
时间窗: 12 weeks post treatment
次要结局
- Change in Local Immunoglobulin E (IgE) Level(baseline, 12 weeks post treatment)
研究者
Kunal R. Shetty
Otolaryngology Resident
The University of Texas Health Science Center, Houston