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

NCT ID: NCT06139185

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 69 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-07-01

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with nasal septum deviation

Data collection

Intervention Type: OTHER

Data collection

Patients without nasal septum deviation

Data collection

Intervention Type: OTHER

Data collection

Interventions

Data collection

Data collection

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Roberto Berni Canani, MD, PhD

Medical Doctor, PhD, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Traslational Medical Science - University of Naples Federico II

Naples, , Italy

University of Naples Federico II

Naples, , Italy

Countries

Italy

Other Identifiers

31/23

Identifier Type: -

Identifier Source: org_study_id