The ARHINASD (Allergic Rhinitis in Pediatric Subjects With Nasal Septum Deviation) Project

Study Overview
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Brief Summary
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Allergic rhinitis is one of the most common inflammatory conditions of the upper airway mucosa, especially in the pediatric population with a prevalence of approximately 25%. It is among the most common chronic inflammatory diseases globally and is caused by IgE-mediated reactions to inhaled allergens, often co-occurring with asthma and causing severe burdens and disabilities worldwide. Allergic rhinitis can in fact seriously compromise the quality of life, significantly influencing school performance, social life and the quality of sleep. It is known that the most common symptoms characterizing allergic rhinitis (itching of the nose, sneezing, rhinorrhea and nasal/sinus obstruction) are partly overlapping with those due to a condition of deviation of the nasal septum and a recent study has shown how 87 % of patients with persistent allergic rhinitis are affected by at least 1 of the 7 types of nasal septum deformity. Deviation of the nasal septum is a very frequent anatomical disorder and is present in up to 48% of children and adolescents in the general population. The deviation narrows the affected nostril canal, reducing the flow of air that passes through the nostrils, predisposing to chronic mucosal inflammation with inflammatory infiltrate and in turn increasing the risk of developing chronic rhinitis and sinusitis. There are no data in the literature that correlate nasal septum deviation with an increased risk of developing allergic rhinitis. Given these premises, the ARHINASD (Allergic Rhinitis in pediatric topics with Nasal Septum Deviation) study was designed with the primary objective of evaluating the presence of allergic rhinitis in a sample of patients with and without deviation of the nasal septum.

Official Title
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ASSOCIATION BETWEEN NASAL SEPTUM DEVIATION AND ALLERGIC RHINITIS IN PEDIATRIC AGE: The ARHINASD (Allergic Rhinitis in Pediatric Subjects With Nasal Septum Deviation) Project

Conditions
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Rhinitis, Allergic

Intervention / Treatment
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* Other: Data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Caucasian ethnicity both sexes age between 6 and 14 years written informed consent. Exclusion Criteria: Non-Caucasian ethnicity Age <6 and >14 years Concomitant presence of: chronic diseases malignancies immunodeficiency chronic infections autoimmune diseases chronic inflammatory intestinal diseases celiac disease genetic diseases metabolic diseases cystic fibrosis chronic pulmonary diseases malformations of the cardiovascular system malformations of the respiratory system malformations of the gastrointestinal system neuropsychiatric disorders neurological diseases obesity eosinophilic diseases antibiotics use in the last 7 days cortisone use in the last 7 days antihistamines use in the last 7 days

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with nasal septum deviation<br> | Other: Data collection<br>* Data collection<br>|
| Patients without nasal septum deviation<br> | Other: Data collection<br>* Data collection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of allergic rhinitis | Complete clinical and anamnestic evaluation and allergy screening test (Skin-Prick Test). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total IgE of nasal wash supernatant | ELISA kit | 12 months | 
| Cytokines (IL-13, IL-9, IL-33, IL-5, INFγ, β-defensin, IL-17, TNFα) of nasal wash supernatant | ELISA kit | 12 months | 
| Quality of life questionnaire | Quality of life questionnaire (VAS) | 12 months | 
| Peak inspiratory nasal flow | PNIF test | 12 months | 
| Nasal cytology | Performed with the nasal scraping to obtain cells which are then stained with May-Grunwald and Giemsa staining and observed using an optical microscope | 12 months |