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

NCT04171167 | Active Not Recruiting

• 1 other identifier: R17011
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis (Diagnosis)

Keywords

Nasal nitric oxide; Nitric oxide metabolites

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• CBCT (Zinreich modified Lund-Mackay) scoring

  Change between visit: 0, +5 weeks, +10weeks

Study Arms (4)

Frequently treated acute rhino sinusitis

ACTIVE COMPARATOR

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

CRSsNP

ACTIVE COMPARATOR

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

Severe CRSsNP and CRSwNP

ACTIVE COMPARATOR

Meets the European position paper criteria of CRS and not included in the first two groups.

Drug: Fluticasone Propionate

Healthy volunteers

NO INTERVENTION

No nasal symptoms or complaints. No interventions done.

Interventions

Fluticasone Propionate DRUG

three visits: 0, after washout, after FP usage

CRSsNP; Frequently treated acute rhino sinusitis; Severe CRSsNP and CRSwNP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Tampere University Hospital

Tampere, Finland

Location

MeSH Terms

Conditions

Disease

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: November 20, 2019
• Study Start: April 4, 2017
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 9, 2023

Record last verified: 2023-04

Locations

FI (1)