The Causal Relation of Nasal Nitric Oxide Levels to the Severity of Chronic Rhinosinusitis and Its Inflammatory Phenotype
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
Drug: Fluticasone Propionate
three visits: 0, after washout, after FP usage
|
| Active Comparator: 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 |
Drug: Fluticasone Propionate
three visits: 0, after washout, after FP usage
|
| Active Comparator: Severe CRSsNP and CRSwNP Meets the European position paper criteria of CRS and not included in the first two groups. |
Drug: Fluticasone Propionate
three visits: 0, after washout, after FP usage
|
| No Intervention: Healthy volunteers No nasal symptoms or complaints. No interventions done. |
Outcome Measures
Primary Outcome Measures
- Nasal nitric oxide levels [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.
- Nitric oxide metabolite (nitrate, nitrite) levels [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 Outcome Measures
- CBCT (Zinreich modified Lund-Mackay) scoring [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients willing to participate in the study
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Patients who are referred to ENT clinic due to chronic rhinosinusitis (EPOS criteria) or repeatedly diagnosed and treated acute rhinosinusitis
Exclusion Criteria:
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Endoscopic sinus surgery operation previously
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Septal deviation that would need an operation to correct the air flow
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Other severe disease that could pose a risk for the patient during the measurements based on the judgement of the treating physician
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Pregnancy or breastfeeding
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Allergy to used medications
-
Inability to co-operate or to tolerate manipulation of the nose
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tampere University Hospital | Tampere | Finland |
Sponsors and Collaborators
- Tampere University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R17011