Short and Mid-term Repeatability of Active Anterior Rhinomanometry (AAR) Measurements in Paediatric Age

Study Overview
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Brief Summary
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Longitudinal, observational study to assess the short-term (test re-test) and mid-term (within the span of 28 days) repeatability of active anterior rhinomanometry (AAR) measures on 4 parallel groups of children with different rhinitis phenotypes, and 1 group of control (healthy) children. Secondary objectives are: i) assessing of association between AAR, exhaled FeNO (eFeNO) and nasal FeNO (nFeNO); ii) assessing association between objective measurements (AAR, eFeNO and nFeNO) and subjective measurements (Total 5 Symptom score, T5SS). The study is intended to obtain useful information for improving rhinitis management.

Official Title
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Short and Mid-term Repeatability of Active Anterior Rhinomanometry (AAR) Measurements in Paediatric Age - Rhino-Rep

Conditions
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Rhinitis, Rhinitis, Allergic, Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial

Participation Criteria
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Eligibility Criteria
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Healthy volunteers (HC) The inclusion criteria for HC are: Negative bronchodilator response; No major nasal septum malformations. The exclusion criteria for HC are: Upper airway infections in the previous 4 weeks; Active smoker; Lifetime history of asthma, rhinitis, or respiratory disease symptoms. Children with non allergic rhinitis (NAR) The inclusion criteria for NAR are: 1.T5SS>5 in the last 4 weeks. The exclusion criteria for NAR are: At least one positive skin prick test for aeroallergens; Upper airway infections in the previous 4 weeks; Active smoker; Major nasal septum malformations. Rhinitis children, perennial allergy (PAR) The inclusion criteria for PAR are: T5SS>5 in the last 4 weeks. At least one positive skin prick test for perennial aeroallergens; The exclusion criteria for PAR are: At least one positive skin prick test for seasonal aeroallergens; Upper airway infections in the previous 4 weeks; Active smoker; Major nasal septum malformations. Rhinitis children, seasonal allergy, outside season (OSR) The inclusion criteria for OSR are: T5SS>5 in the last 4 weeks. At least one positive skin prick test for seasonal aeroallergens; The exclusion criteria for OSR are: At least one positive skin prick test for perennial aeroallergens; Upper airway infections in the previous 4 weeks; Active smoker; Major nasal septum malformations. Rhinitis children, seasonal allergy, within season (OSR) The inclusion criteria for OSR are: T5SS>5 in the last 4 weeks. At least one positive skin prick test for seasonal aeroallergens; The exclusion criteria for OSR are: At least one positive skin prick test for perennial aeroallergens; Upper airway infections in the previous 4 weeks; Active smoker; Major nasal septum malformations.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy children (HC)<br>10 healthy children | |
| Children with non allergic rhinitis (NAR)<br>10 children with non allergic rhinitis | |
| Rhinitis children, perennial allergy (PAR)<br>10 rhinitis children, sensitized to perennial allergens | |
| Rhinitis children, seasonal allergy, outside season (OSR)<br>10 rhinitis children sensitized to seasonal allergens, observed outside the allergen season | |
| Rhinitis children, seasonal allergy, within season (WSR)<br>10 rhinitis children sensitized to seasonal allergens, observed during the allergen season | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short term repeatability of active anterior rhinomanometry (AAR) | For each individual, it will be calculated the coefficient of variation of 5 measurements of AAR taken within 30 minutes, at baseline. | 1 day | 
| Mid term repeatability of active anterior rhinomanometry (AAR) | For each individual, it will be calculated the coefficient of variation of 3 measurements of AAR taken at baseline and then twice more within the span of 28 days (after one week and after two weeks). | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between AAR and oral FeNO | Correlation coefficients between measurements of AAR and oral FeNO (at each visit the mean of 3 consecutive measurements of oral FeNO is considered) | 28 days | 
| Correlation between AAR and nasal FeNO | Correlation coefficients between measurements of AAR and nasal FeNO (at each visit the mean of 3 consecutive measurements of nasal FeNO is considered) | 28 days | 
| Correlation between AAR (objective perspective) and T5SS (subjective perspective) | Correlation coefficients between measurements of AAR and total 5 symptom score | 28 days | 
| Correlation between FeNO (objective perspective) and T5SS (subjective perspective) | Correlation coefficients between measurements of FeNO and total 5 symptom score | 28 days |