The Effect of Aspirin Desensitization on Patients With Aspirin-exacerbated Respiratory Diseases
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in SNOT-22 scores from Baseline
研究概览
简要总结
The purpose of this study is to determine the effect of aspirin desensitization on symptoms and immunologic profile of patients with aspirin-exacerbated respiratory diseases (AERD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinical diagnose of aspirin-exacerbated respiratory disease
- •History of physician diagnosed asthma.
- •History of physiacian diagnosed chronic rhinosinositis with nasal polyps.
- •Positive reaction to aspirin challenge test.
- •Stable asthma (post-bronchodilator FEV1 of 70% or better, no increase in baseline dose of oral glucocorticoids for at least 3 months, and no history of hospitalization or emergency room visits for asthma for at least the prior 6 months).
排除标准
- •Being smoker
- •pregnancy
- •Current breastfeeding
- •History of bleeding diathesis
- •History of transient ischemic attack or stroke, or diabetes.
- •History of abnormal hepatic function
- •Uncontrolled hypertension or use of beta blocker medication.
- •History of gastrointestinal ulcers or gastrointestinal bleeding.
研究组 & 干预措施
Intervention: Aspirin
Participants will undergo aspirin desensitization over a 2-day period with increasing doses of aspirin (60, 125, 325 and 625 mg). Thereafter,they will be followed with 625 mg aspirin bid.
干预措施: aspirin (Drug)
结局指标
主要结局
Change in SNOT-22 scores from Baseline
时间窗: 6 months
At baseline and 6 months after treatment, all participants will complete the SNOT-22 questionnaire. SNOT-22 is a validated disease specific questionnaire that assesses the health related quality of life patients.
change in serum concentration of IL-10
时间窗: 6 months
At baseline and 6 months after treatment, serum level of IL-10 will be investigated for all participants.
change in concentration of serum TGF-beta
时间窗: 6 months
At baseline and 6 months after treatment, serum level of TGF-beta will be investigated for all participants
change in concentration of serum IFN-gamma
时间窗: 6 months
At baseline and 6 months after treatment, serum level of IFN-gamma will be investigated for all participants.
次要结局
- Lund Mackay score(6 months)
- Asthma attacks(6 months)
- medication needs(6 months)
- FEV1(6 months)