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

Primary Purpose

Chronic Rhinosinusitis (Diagnosis)

Status

Active

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Fluticasone Propionate

About this trial

This is an interventional diagnostic trial for Chronic Rhinosinusitis (Diagnosis) focused on measuring Nasal nitric oxide, Nitric oxide metabolites

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Tampere University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

No Intervention

Arm Label

Frequently treated acute rhino sinusitis

CRSsNP

Severe CRSsNP and CRSwNP

Healthy volunteers

Arm Description

Does not meet the European position paper criteria of CRS: asymptomatic periods in between and no objective findings when entering the study.

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

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

No nasal symptoms or complaints. No interventions done.

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04171167

First Posted

October 23, 2018

Last Updated

May 8, 2023

Sponsor

Tampere University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04171167

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 4, 2017 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tampere University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Rhinosinusitis (Diagnosis)

Keywords

Nasal nitric oxide, Nitric oxide metabolites

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Frequently treated acute rhino sinusitis

Arm Type

Active Comparator

Arm Description

Does not meet the European position paper criteria of CRS: asymptomatic periods in between and no objective findings when entering the study.

Arm Title

CRSsNP

Arm Type

Active Comparator

Arm Description

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

Arm Title

Severe CRSsNP and CRSwNP

Arm Type

Active Comparator

Arm Description

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

Arm Title

Healthy volunteers

Arm Type

No Intervention

Arm Description

No nasal symptoms or complaints. No interventions done.

Intervention Type

Drug

Intervention Name(s)

Fluticasone Propionate

Intervention Description

three visits: 0, after washout, after FP usage

Primary Outcome Measure Information:

Title

Nasal nitric oxide levels

Description

Gaseous nitric oxide is measured nasal cavity and maxillary sinuses using EcoMedics CLD 88p analyser (ppb). Procedure according to ERS protocol.

Time Frame

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

Title

Nitric oxide metabolite (nitrate, nitrite) levels

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

CBCT (Zinreich modified Lund-Mackay) scoring

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Tampere University Hospital

City

Tampere

Country

Finland

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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