The Causal Relation of Nasal Nitric Oxide Levels to the Severity of Chronic Rhinosinusitis and Its Inflammatory Phenotype

Study Overview
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Brief Summary
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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.

Official Title
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The Causal Relation of Nasal Nitric Oxide Levels to the Severity of Chronic Rhinosinusitis and Its Inflammatory Phenotype

Conditions
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Chronic Rhinosinusitis (Diagnosis)

Intervention / Treatment
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* Drug: Fluticasone Propionate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Frequently treated acute rhino sinusitis<br>Does not meet the European position paper criteria of CRS: asymptomatic periods in between and no objective findings when entering the study. | Drug: Fluticasone Propionate<br>* three visits: 0, after washout, after FP usage<br>|
| Active Comparator: CRSsNP<br>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 | Drug: Fluticasone Propionate<br>* three visits: 0, after washout, after FP usage<br>|
| Active Comparator: Severe CRSsNP and CRSwNP<br>Meets the European position paper criteria of CRS and not included in the first two groups. | Drug: Fluticasone Propionate<br>* three visits: 0, after washout, after FP usage<br>|
| No Intervention: Healthy volunteers<br>No nasal symptoms or complaints. No interventions done. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal nitric oxide levels | Gaseous nitric oxide is measured nasal cavity and maxillary sinuses using EcoMedics CLD 88p analyser (ppb). Procedure according to ERS protocol. | Change between visit: 0, +5 weeks, +10weeks | 
| Nitric oxide metabolite (nitrate, nitrite) levels | 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 | Change between visit: 0, +5 weeks, +10weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CBCT (Zinreich modified Lund-Mackay) scoring | A routine high resolution cone beam computed tomography (CBCT) is done to evaluate the initial status of the patients nose and repeated (with ultra-low-dose protocol) at every visit to demonstrate the the current state. Opasification score scale 0-5, max. 50 and obstruction score 0-1 (0,5 steps), max. 8. | Change between visit: 0, +5 weeks, +10weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nitric oxide metabolites, Nasal nitric oxide