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

Tampere University Hospital

Status: Active, not recruiting

Conditions: Chronic Rhinosinusitis (Diagnosis)

Treatments: Drug: Fluticasone Propionate

Study type: Interventional

Funder types: Other

Identifiers

NCT04171167

R17011

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 4 patient groups

Frequently treated acute rhino sinusitis

Active Comparator group

Description:

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

Treatment:

Drug: Fluticasone Propionate

CRSsNP

Active Comparator group

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

Treatment:

Drug: Fluticasone Propionate

Severe CRSsNP and CRSwNP

Active Comparator group

Description:

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

Treatment:

Drug: Fluticasone Propionate

Healthy volunteers

No Intervention group

Description:

No nasal symptoms or complaints. No interventions done.