Nasal Allergen Challenge - Reproducibility of Biomarkers and Effect of Topical Steroid Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cellular inflammation
研究概览
简要总结
Subjects with allergic asthma developing the required nasal symptoms in response to nasal allergen titration during a screening period will be randomized 1:1 to one of 2 cohorts. All subjects will have repeated nasal challenges with allergen. One cohort will have nasal saline challenge as control. One cohort will have intranasal corticosteroid intervention.
详细描述
Eligible subjects will be randomized 1:1 to Cohort A or Cohort B. Each cohort will undergo 3 nasal challenges, each separated by 3 weeks. Cohort A will undergo 2 nasal allergen challenges, and 1 nasal diluent challenge. TNSS, PNIF, spirometry, and samples of blood, urine and nasal secretions will be collected until 24h post-challenge to assess reproducibility. Cohort B will undergo 3 nasal allergen challenges; one of the challenge will be conducted after 14 days treatment with placebo, and one challenge will be conducted after 14 days treatment with triamcinolone acetonide aqueous nasal spray at a dose of 220 mcg administered twice daily for a total daily dose of 440 mcg. TNSS, PNIF, spirometry, and samples of blood, urine, nasal secretions will be collected until 24h post-challenge to determine reproducibility, and nasal tissue will be collected 24h post-challenge to determine effect of steroid treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •allergic rhinitis + mild asthma
排除标准
- •other respiratory disease
- •any medication for treatment of asthma/allergic rhinitis with the exception of infrequent beta-2 agonist.
研究组 & 干预措施
Placebo
0.9% normal saline administered twice daily for 14 days
干预措施: Placebo (Drug)
Intranasal Corticosteroid
Triamcinolone acetonide aqueous nasal spray at a dose of 220 mcg administered twice daily (for a total daily dose of 440 mcg) for 14 days
干预措施: Triamcinolone Acetonide (Drug)
结局指标
主要结局
Cellular inflammation
时间窗: 24 hours after nasal allergen challenge
Nasal eosinophils
次要结局
未报告次要终点
研究者
Gail Gauvreau
Professor
Hamilton Health Sciences Corporation