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

NCT06139185 | Completed

• 1 other identifier: 31/23
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Rhinitis, Allergic

Outcome Measures

Primary Outcomes (1)

• Presence of allergic rhinitis

  Complete clinical and anamnestic evaluation and allergy screening test (Skin-Prick Test).

  12 months

Secondary Outcomes (5)

• Total IgE of nasal wash supernatant

  12 months

• Cytokines (IL-13, IL-9, IL-33, IL-5, INFγ, β-defensin, IL-17, TNFα) of nasal wash supernatant

  12 months

• Quality of life questionnaire

  12 months

• Peak inspiratory nasal flow

  12 months

• Nasal cytology

  12 months

Study Arms (2)

Patients with nasal septum deviation

Other: Data collection

Patients without nasal septum deviation

Other: Data collection

Interventions

Data collection OTHER

Data collection

Patients with nasal septum deviation; Patients without nasal septum deviation

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• Caucasian ethnicity
• both sexes
• age between 6 and 14 years
• written informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (2)

Department of Traslational Medical Science - University of Naples Federico II

Naples, 80131, Italy

Location

University of Naples Federico II

Naples, Italy

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, PhD, Professor

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 18, 2023
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: July 1, 2024
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)