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临床试验/NCT03893227
NCT03893227已完成不适用

Prevalence of Nasal Hyperreactivity in Chronic Upper Airway Inflammation: a Prevalence Study

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 756 人开始时间: 2019年1月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
756
试验地点
1
主要终点
Comparison of the proportion of patients and healthy volunteers with nasal hyperreactivity

研究概览

简要总结

Rhinitis, or inflammation of the nasal mucosa, can present with nasal obstruction, nasal discharge, itch or sneezing. If the sinusal mucosa is involved as well, it is called rhinosinusitis and facial pain or loss of smell is possible. Several causes are known, such as an underlying allergy ("allergic rhinitis", AR). If at least 2 symptoms are present for at least 12 weeks, it is called "chronic rhinosinusitis" (CRS).

Up to 2/3 of the AR and CRS patients have symptoms upon exposure to triggers such as sudden temperature changes, smoke, fragrances... a phenomenon called "nasal hyperreactivity" (NHR). It is currently not clear why some patients suffer NHR while others do not.

In this study, the investigators want to determine the prevalence and severity of nasal hyperreactivity in patients with chronic upper airway inflammation. To this end, patients and healthy controls will be asked to fill out a questionnaire inquiring presence and severity of nasal symptoms upon exposure to particular environmental triggers.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18-65 y
  • Nasal inflammatory symptoms for 12 weeks or longer (nasal obstruction, post-nasal drip, rhinorrhea, loss of smell, sneezing/itch, facial pain)
  • Signed informed consent

排除标准

  • Current or medical history of malignancy in the last ten years
  • Inclusion Criteria:
  • age 18-65 y
  • No nasal inflammatory symptoms for 12 weeks or longer (nasal obstruction, post-nasal drip, rhinorrhea, loss of smell, sneezing/itch, facial pain)
  • Signed informed consent
  • Exclusion Criteria:
  • Current or medical history of malignancy in the last ten years

结局指标

主要结局

Comparison of the proportion of patients and healthy volunteers with nasal hyperreactivity

时间窗: 3 months

Every participant will fill out a questionnaire inquiring presence of nasal symptoms evoked by environmental triggers and lasting longer than ten minutes (nasal hyperreactivity). The proportion of patients and healthy volunteers with nasal hyperreactivity will be compared.

次要结局

  • Comparison of the proportion of healthy volunteers and four groups of patients (allergic rhinitis, non-allergic non-infectious rhinitis, chronic rhinosinusitis with nasal polyps, chronic rhinosinusitis without nasal polyps) with nasal hyperreactivity.(3 months)
  • Comparison of nasal symptom severity in healthy volunteers and four groups of patients [allergic rhinitis, non-allergic non-infectious rhinitis, chronic rhinosinusitis (CRS) with and CRS without nasal polyps] with and without nasal hyperreactivity.(3 months)
  • Comparison of nasal symptom severity in patients and healthy volunteers with and without nasal hyperreactivity.(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laura Van Gerven

Professor doctor

Universitaire Ziekenhuizen KU Leuven

研究点 (1)

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