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

Rhinitis, Allergic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06139185
• Other study ID #: 31/23
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: November 2023
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 69
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic

Intervention

Other:
• Data collection
Data collection

Locations

Country	Name	City	State
Italy	Department of Traslational Medical Science - University of Naples Federico II	Naples
Italy	University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of allergic rhinitis	Complete clinical and anamnestic evaluation and allergy screening test (Skin-Prick Test).	12 months
Secondary	Total IgE of nasal wash supernatant	ELISA kit	12 months
Secondary	Cytokines (IL-13, IL-9, IL-33, IL-5, INF?, ß-defensin, IL-17, TNFa) of nasal wash supernatant	ELISA kit	12 months
Secondary	Quality of life questionnaire	Quality of life questionnaire (VAS)	12 months
Secondary	Peak inspiratory nasal flow	PNIF test	12 months
Secondary	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