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临床试验/NCT06139185
NCT06139185已完成不适用

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

Federico II University2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
69
试验地点
2
主要终点
Presence of allergic rhinitis

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
6 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Caucasian ethnicity
  • both sexes
  • age between 6 and 14 years
  • written informed consent.

排除标准

  • 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
  • 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

结局指标

主要结局

Presence of allergic rhinitis

时间窗: 12 months

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

次要结局

  • Total IgE of nasal wash supernatant(12 months)
  • Peak inspiratory nasal flow(12 months)
  • Nasal cytology(12 months)
  • Quality of life questionnaire(12 months)
  • Cytokines (IL-13, IL-9, IL-33, IL-5, INFγ, β-defensin, IL-17, TNFα) of nasal wash supernatant(12 months)

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberto Berni Canani, MD, PhD

Medical Doctor, PhD, Professor

Federico II University

研究点 (2)

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