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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04171167
Enrollment
88
Registered
2019-11-20
Start date
2017-04-04
Completion date
2026-12-31
Last updated
2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Rhinosinusitis (Diagnosis)

Keywords

Nasal nitric oxide, Nitric oxide metabolites

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.

Interventions

DRUGFluticasone Propionate

three visits: 0, after washout, after FP usage

Sponsors

Tampere University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Nasal nitric oxide levelsChange between visit: 0, +5 weeks, +10weeksGaseous 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) levelsChange between visit: 0, +5 weeks, +10weeksNO 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

MeasureTime frameDescription
CBCT (Zinreich modified Lund-Mackay) scoringChange between visit: 0, +5 weeks, +10weeksA 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.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026