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

Not Applicable

Active, not recruiting

• Conditions: Chronic Rhinosinusitis (Diagnosis)
• Interventions: Drug: Fluticasone Propionate

• Registration Number: NCT04171167
• Lead Sponsor: Tampere University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-04
• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2019-11-18
• Study First Posted: 2019-11-20
• Status Verified: 2023-04
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Severe CRSsNP and CRSwNP	Fluticasone Propionate	Meets the European position paper criteria of CRS and not included in the first two groups.
Frequently treated acute rhino sinusitis	Fluticasone Propionate	Does not meet the European position paper criteria of CRS: asymptomatic periods in between and no objective findings when entering the study.
CRSsNP	Fluticasone Propionate	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

Primary Outcome Measures

Name	Time	Method
Nasal nitric oxide levels	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	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

Secondary Outcome Measures

Name	Time	Method
CBCT (Zinreich modified Lund-Mackay) scoring	Change between visit: 0, +5 weeks, +10weeks	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.

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland