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NCT Number: NCT06139185

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

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.

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Key information

Conditions

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

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Traslational Medical Science - University of Naples Federico II, Naples, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

Data collection

Primary outcomes

  1. Presence of allergic rhinitis

    Time frame: 12 months

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

Secondary outcomes

  1. Total IgE of nasal wash supernatant

    Time frame: 12 months

    ELISA kit

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

    Time frame: 12 months

    ELISA kit

  3. Quality of life questionnaire

    Time frame: 12 months

    Quality of life questionnaire (VAS)

  4. Peak inspiratory nasal flow

    Time frame: 12 months

    PNIF test

  5. Nasal cytology

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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