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

• Sponsor: Federico II University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06139185
• Collaborator: (none)
• Enrollment: 69
• Locations: 2
• Anticipated Duration (Months): 12
• Patients Per Site: 34.5
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhinitis, Allergic	Other: Data collection

Study Design

• Study Type: Observational
• Anticipated Enrollment: 69 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• 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"
• Actual Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Presence of allergic rhinitis [12 months]

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

Secondary Outcome Measures

1. Total IgE of nasal wash supernatant [12 months]

   ELISA kit

2. Cytokines (IL-13, IL-9, IL-33, IL-5, INFγ, β-defensin, IL-17, TNFα) of nasal wash supernatant [12 months]

   ELISA kit

3. Quality of life questionnaire [12 months]

   Quality of life questionnaire (VAS)

4. Peak inspiratory nasal flow [12 months]

   PNIF test

5. Nasal cytology [12 months]

   Performed with the nasal scraping to obtain cells which are then stained with May-Grunwald and Giemsa staining and observed using an optical microscope

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Traslational Medical Science - University of Naples Federico II	Naples		Italy	80131
2	University of Naples Federico II	Naples		Italy

Sponsors and Collaborators

• Federico II University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roberto Berni Canani, MD, PhD, Medical Doctor, PhD, Professor, Federico II University
• ClinicalTrials.gov Identifier: NCT06139185
• Other Study ID Numbers: 31/23
• First Posted: Nov 18, 2023
• Last Update Posted: Nov 28, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic

Study Results

No Results Posted as of Nov 28, 2023