Evaluation of Nasal Inflammatory Biomarkers During the Early and Late Phase Response to Nasal Volus Allergen Challenge in in Subjects With Seasonal Allergic Rhinitis (Out-of-season)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Interleukin-4
研究概览
简要总结
This research aims to establish a panel of inflammatory biomarkers of the early (Histamine, Tryptase, ProstaglandineD2) and late (Interleukin-4, Interleukin-5, Interleukin-6, Interleukin-13, Eotaxin, Tumor necrosis factor-a (TNF), (Macrophage Inflammatory Protein-1beta (MIP1ß)) phase response to nasal bolus allergen challenge (NAC) in subjects with out-of-season seasonal allergic rhinitis, suitable for future application in drug intervention studies of novel anti-allergy therapeutics.
详细描述
Biomarkers will be sampled by nasal filter paper (NFP) adsorption and lavage (NLF) prior to and following NAC. Samples from initial subjects (Cohort A; n~6) will be used primarily for validation of biomarker assays in nasal filter paper eluates. Validated biomarker assays will be applied to analyze biomarker changes in a further cohort of subjects (Cohort B; n~12) with the aim of fully defining the optimum panel and sampling time points for future studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Able and willing to give written informed consent.
- •Male or female, age 18-65 years.
- •Women will be considered for inclusion if they are:
- •Not pregnant, as confirmed by pregnancy test, and not nursing.
- •Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchal, or post-menopausal with documented proof of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit).
- •Of childbearing potential and using a highly effective method of contraception during the entire study, as defined by at least one of the following
- •vasectomised partner
- •sexual abstinence (the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to Visit 2 procedures until at least 72 hours after NAC)
- •implants, injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods (i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap)
- •History of seasonal allergic rhinitis to grass pollen with symptoms during the 2016 and 2017 allergen season requiring treatment with anti-histamines, nasal corticosteroids or leukotriene antagonists.
- •Absence of significant current symptoms of allergic rhinitis consistent with being out of season for their principal allergen (eg grass).
- •Skin prick test positive for mixed grass pollen allergen at Visit 1 or within one year prior to screening.
排除标准
- •Asthma requiring more than inhaled short-acting beta-2 agonists.
- •Spirometry showing FEV1 <80% predicted
- •Subjects who have smoked more than 5 cigarettes in the last 6 months or have a smoking history of ≥10 pack years.
- •Upper or lower respiratory tract infection in the prior 4 weeks.
- •Nasal or lung provocation procedure (eg, allergen challenge) conducted in the prior 4 weeks.
- •Significant nasal deformity, recent nasal surgery or obstructing nasal polyps.
- •History of anaphylaxis (any cause), or previous severe hypersensitivity reaction to any of the test agents for SPT or NAC.
- •Recent participation in a study of an investigational medicinal product (IMP) which could interfere with markers evaluated in this research
- •Use of any medications according to section 5.2 in the period indicated before Visit 1
研究组 & 干预措施
NAC (no drug/no device) and NFP
NAC with mixed grass pollen will be conducted. Nasal mucosal inflammatory mediators will be collected via nasal filter paper (NFP)
干预措施: NAC (no drug/no device) (Other)
NAC (no drug/no device) and NFP AND NLF
NAC with mixed grass pollen will be conducted. Nasal filter paper (NFP)sampling will be conducted from one nostril per time point. Subjects in Cohort B will also undergo nasal lavage (NLF) pre-NAC and at serial time points thereafter up to 8 hours
干预措施: NAC (no drug/no device) (Other)
结局指标
主要结局
Interleukin-4
时间窗: Change from baseline at time points: 1 minutes (min), 4 min, 7 min, 10 min, 15 min, 30 min, 60 min, 120 min, 240 min, 360 min, 480 min
Interlukin- 4 \[pg/ml\] using ELISA assays
次要结局
未报告次要终点