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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Rhinosinusitis (Diagnosis)
• Intervention / Treatment: Drug: Fluticasone Propionate

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tamminen; Phone Number: +358 03 311611; Email: studyregp@gmail.com

Study Locations

• Finland
  • Tampere, Finland
    • Tampere University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Fluticasone Propionate; three visits: 0, after washout, after FP usage
Active Comparator: 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	Drug: Fluticasone Propionate; three visits: 0, after washout, after FP usage
Active Comparator: Severe CRSsNP and CRSwNP; Meets the European position paper criteria of CRS and not included in the first two groups.	Drug: Fluticasone Propionate; three visits: 0, after washout, after FP usage
No Intervention: Healthy volunteers; No nasal symptoms or complaints. No interventions done.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tampere University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2017
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Nasal nitric oxide; Nitric oxide metabolites
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Fluticasone; Xhance
• Other Study ID Numbers: R17011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No