The Causal Relation of Nasal Nitric Oxide Levels to the Severity of Chronic Rhinosinusitis and Its Inflammatory Phenotype
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Nasal nitric oxide levels
研究概览
简要总结
Nitric oxide (NO) reflects changes in inflammatory state of the airways. In pulmonology fractional exhaled nitric oxide concentration (FeNO) has been linked to eosinophilic asthma and is used to guide overall disease control. The measurement of nasal nitric oxide (nNO) may reflect the disease burden and inflammatory phenotype of the paranasal sinuses.
The aim of our study is to evaluate the relation of chronic rhino sinusitis (CRS) severity and inflammatory status to nNO, maxillary sinus NO, nitrite, nitrate and cone beam computed tomography (CBCT).
Three groups (22 patients in each) of referred patients and and 22 healthy volunteers are recruited. Patients are grouped according to the CBCT score and viewed three times in 4-6 weeks intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients willing to participate in the study
- •Patients who are referred to ENT clinic due to chronic rhinosinusitis (EPOS criteria) or repeatedly diagnosed and treated acute rhinosinusitis
排除标准
- •Endoscopic sinus surgery operation previously
- •Septal deviation that would need an operation to correct the air flow
- •Other severe disease that could pose a risk for the patient during the measurements based on the judgement of the treating physician
- •Pregnancy or breastfeeding
- •Allergy to used medications
- •Inability to co-operate or to tolerate manipulation of the nose
研究组 & 干预措施
Frequently treated acute rhino sinusitis
Does not meet the European position paper criteria of CRS: asymptomatic periods in between and no objective findings when entering the study.
干预措施: Fluticasone Propionate (Drug)
CRSsNP
Meets the European position paper criteria of CRS. Zinreich modification of Lund-Mackey scoringing: Opacification score < 21 and obstruction score 0-8. No visible nasal polyps in endoscopy
干预措施: Fluticasone Propionate (Drug)
Severe CRSsNP and CRSwNP
Meets the European position paper criteria of CRS and not included in the first two groups.
干预措施: Fluticasone Propionate (Drug)
结局指标
主要结局
Nasal nitric oxide levels
时间窗: Change between visit: 0, +5 weeks, +10weeks
Gaseous nitric oxide is measured nasal cavity and maxillary sinuses using EcoMedics CLD 88p analyser (ppb). Procedure according to ERS protocol.
Nitric oxide metabolite (nitrate, nitrite) levels
时间窗: Change between visit: 0, +5 weeks, +10weeks
NO production is determined from saline lavage of nasal cavity and maxillary sinus by measuring the accumulation of nitrite, a stable metabolite of NO in aqueous milieu, by the Griess reaction
次要结局
- CBCT (Zinreich modified Lund-Mackay) scoring(Change between visit: 0, +5 weeks, +10weeks)