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

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

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.

Study Overview

• Status: Completed
• Conditions: Rhinitis, Allergic
• Intervention / Treatment: Other: Data collection

• Study Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy
    • University of Naples Federico II
  • Naples, Italy, 80131
    • Department of Traslational Medical Science - University of Naples Federico II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Caucasian children of both sexes aged between 6 and 14 with and without suspected deviation of the nasal septum observed at Pediatrics Section of Department of Translational Medical Sciences (University of Naples Federico II), University of Calabria (Department of Pharmacy, Health and Nutrition Sciences) and Otorhinolaryngology Unit, Penne Hospital, ASL of Pescara

Description

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
• trauma at nose level in the 3 years before the enrollment,
• history of previous nose surgery, or previous major surgery procedures of gastrointestinal, cardiovascular, urinary or respiratory tract

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with nasal septum deviation	Other: Data collection; Data collection
Patients without nasal septum deviation	Other: Data collection; Data collection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Data Collection
• Other Study ID Numbers: 31/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No