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

NCT ID: NCT04171167

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-04

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Rhinosinusitis (Diagnosis)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Frequently treated acute rhino sinusitis

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

Group Type ACTIVE_COMPARATOR

Fluticasone Propionate

Intervention Type DRUG

three visits: 0, after washout, after FP usage

CRSsNP

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

Group Type ACTIVE_COMPARATOR

Fluticasone Propionate

Intervention Type DRUG

three visits: 0, after washout, after FP usage

Severe CRSsNP and CRSwNP

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

Group Type ACTIVE_COMPARATOR

Fluticasone Propionate

Intervention Type DRUG

three visits: 0, after washout, after FP usage

Healthy volunteers

No nasal symptoms or complaints. No interventions done.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fluticasone Propionate

three visits: 0, after washout, after FP usage

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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R17011

Identifier Type: -

Identifier Source: org_study_id

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