Clinical trial NCT06139185: The ARHINASD (Allergic Rhinitis in Pediatric Subjects With Nasal Septum Deviation) Project
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"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis, Allergic
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 69
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caucasian children of both sexes aged between 6 and 14 with suspected deviation of the nasal septum observed at Pediatrics Section of Department of Translational Medical Sciences (University of Naples Federico II)

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.


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

Primary outcomes:
measure: Presence of allergic rhinitis
timeFrame: 12 months
Secondary outcomes:
measure: Total IgE of nasal wash supernatant
timeFrame: 12 months
measure: Cytokines (IL-13, IL-9, IL-33, IL-5, INFγ, β-defensin, IL-17, TNFα) of nasal wash supernatant
timeFrame: 12 months
measure: Quality of life questionnaire
timeFrame: 12 months
measure: Peak inspiratory nasal flow
timeFrame: 12 months
measure: Nasal cytology
timeFrame: 12 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Traslational Medical Science - University of Naples Federico II
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
References: