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

Chronic Rhinosinusitis (Diagnosis) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04171167
• Other study ID #: R17011
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 4, 2017
• Est. completion date: December 2026

Study information

• Verified date: April 2023
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 88
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis (Diagnosis)
• Sinusitis

Intervention

Drug:
• Fluticasone Propionate
three visits: 0, after washout, after FP usage

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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