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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with nasal septum deviation |
| ||
| Patients without nasal septum deviation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | Data collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of allergic rhinitis | Complete clinical and anamnestic evaluation and allergy screening test (Skin-Prick Test). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total IgE of nasal wash supernatant | ELISA kit | 12 months |
| Cytokines (IL-13, IL-9, IL-33, IL-5, INFγ, β-defensin, IL-17, TNFα) of nasal wash supernatant | ELISA kit |
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Inclusion Criteria:
Exclusion Criteria:
Concomitant presence of:
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Caucasian children of both sexes aged between 6 and 14 with and without suspected deviation of the nasal septum observed at Pediatrics Section of Department of Translational Medical Sciences (University of Naples Federico II), University of Calabria (Department of Pharmacy, Health and Nutrition Sciences) and Otorhinolaryngology Unit, Penne Hospital, ASL of Pescara
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Traslational Medical Science - University of Naples Federico II | Naples | 80131 | Italy | |||
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| 12 months |
| Quality of life questionnaire | Quality of life questionnaire (VAS) | 12 months |
| Peak inspiratory nasal flow | PNIF test | 12 months |
| 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 |
| University of Naples Federico II |
| Naples |
| Italy |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |