Identification of Mediators Associated With Presence of Nasal Hyperreactivity in Allergic Rhinitis and Chronic Rhinosinusitis
试验速览
- 阶段
- 不适用
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Objective 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 identify the mediators associated with NHR in patients with allergic rhinitis, chronic rhinosinusitis and healthy control subjects.To do so, participants will be provoked with cold, dry air in order to objectively diagnose NHR. Before and after provocation, the peak nasal inspiratory flow will be measured and samples will be collected (nasal secretions, biopsies).
详细描述
Patients with perennial allergic rhinitis, chronic rhinosinusitis with nasal polyps and healthy control subjects will be recruited. At baseline, nasal secretions and mucosal biopsies will be collected. After 3 weeks, participants will be provoked with cold, dry air, and samples will be harvested again. A decrease in the peak nasal inspiratory flow of >20% will be used as a cutoff to define nasal hyperreactivity.
Nasal secretions will be analysed for various mediators using a multiplex assay. The biopsies will be used for RT-q-PCR and immunohistochemistry of various transient receptor potential (TRP) channels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- 是
入选标准
- •18-65 years
- •positive skin prick test for house dust mite (for allergic rhinitis group), presence of nasal polyps (for chronic rhinosinusitis with nasal polyps group)
- •VAS-score >5 for rhino(sinus)itis symptoms
排除标准
- •positive skin prick test (for chronic rhinosinusitis with nasal polyps group and healthy control group), presence of nasal polyps (for allergic rhinitis group and healthy control group)
- •Acute rhinitis in the past 2 weeks
- •(History of) immunotherapy for house dust mite
- •Relevant anatomic abnormalities
- •Participation in another clinical trial at the moment of this study.
- •Use of anticoagulants (apart from acetylsalicylic acid)
- •Use of tricyclic antidepressants
- •History of intranasal drug usage in the past 12 months
- •Pregnancy or breastfeeding
- •Malignancy or severe comorbidity
结局指标
主要结局
Objective nasal hyperreactivity
时间窗: 3 weeks
The peak nasal inspiratory flow will be measured before and after provocation with cold, dry air. A decrease of \>20% will be used as a cutoff to objectively diagnose nasal hyperreactivity.
次要结局
- Levels of histamine in nasal secretions(3 weeks)
- Levels of substance P in nasal secretions(3 weeks)
- Levels of neurokinin A in nasal secretions(3 weeks)
- Levels of calcitonin gene-related peptide in nasal secretions(3 weeks)
- Levels of IL-13 in nasal secretions(3 weeks)
- Presence of TRP Vanilloid 1 in nasal mucosa.(3 weeks)
- Levels of tryptase in nasal secretions(3 weeks)
- Levels of neurokinin B in nasal secretions(3 weeks)
- Levels of IL-5 in nasal secretions(3 weeks)
- Levels of interleukin (IL) 4 in nasal secretions(3 weeks)
- Presence of TRP Ankyrin 1 in nasal mucosa.(3 weeks)
- Presence of TRP Melastatin 8 in nasal mucosa.(3 weeks)
研究者
Laura Van Gerven
Professor doctor
Universitaire Ziekenhuizen KU Leuven