The ARHINASD (Allergic Rhinitis in Pediatric Subjects With Nasal Septum Deviation) Project
- Conditions
- Rhinitis, Allergic
- Interventions
- Other: Data collection
- Registration Number
- NCT06139185
- Lead Sponsor
- Federico II University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 69
- Caucasian ethnicity
- both sexes
- age between 6 and 14 years
- written informed consent.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with nasal septum deviation Data collection - Patients without nasal septum deviation Data collection -
- Primary Outcome Measures
Name Time Method Presence of allergic rhinitis 12 months Complete clinical and anamnestic evaluation and allergy screening test (Skin-Prick Test).
- Secondary Outcome Measures
Name Time Method Peak inspiratory nasal flow 12 months PNIF test
Total IgE of nasal wash supernatant 12 months ELISA kit
Quality of life questionnaire 12 months Quality of life questionnaire (VAS)
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
Cytokines (IL-13, IL-9, IL-33, IL-5, INFγ, β-defensin, IL-17, TNFα) of nasal wash supernatant 12 months ELISA kit
Trial Locations
- Locations (2)
University of Naples Federico II
🇮🇹Naples, Italy
Department of Traslational Medical Science - University of Naples Federico II
🇮🇹Naples, Italy