Skip to content

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06139185
Enrollment
69
Registered
2023-11-18
Start date
2023-01-01
Completion date
2024-07-01
Last updated
2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis, Allergic

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.

Interventions

OTHERData collection

Data collection

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Presence of allergic rhinitis12 monthsComplete clinical and anamnestic evaluation and allergy screening test (Skin-Prick Test).

Secondary

MeasureTime frameDescription
Total IgE of nasal wash supernatant12 monthsELISA kit
Cytokines (IL-13, IL-9, IL-33, IL-5, INFγ, β-defensin, IL-17, TNFα) of nasal wash supernatant12 monthsELISA kit
Quality of life questionnaire12 monthsQuality of life questionnaire (VAS)
Peak inspiratory nasal flow12 monthsPNIF test
Nasal cytology12 monthsPerformed with the nasal scraping to obtain cells which are then stained with May-Grunwald and Giemsa staining and observed using an optical microscope

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026