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NCT Number: NCT04171167

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Rhinosinusitis (Diagnosis) Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampere University Hospital

Tampere, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluticasone propionate

Drug

three visits: 0, after washout, after FP usage

Primary outcomes

  1. Nasal nitric oxide levels

    Time frame: 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.

  2. Nitric oxide metabolite (nitrate, nitrite) levels

    Time frame: 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 outcomes

  1. CBCT (Zinreich modified Lund-Mackay) scoring

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2025
Study completion
2026
First posted
Nov 20, 2019
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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