Therapeutic Control of Aspirin-Exacerbated Respiratory Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Provocative Dose 2 (PD2) During Aspirin Challenge
研究概览
简要总结
The overall aim of the study is to determine the efficacy of oral ifetroban, a novel antagonist of T prostanoid (TP) receptors, as a treatment for patients with aspirin-exacerbated respiratory disease (AERD).
详细描述
The protocol involves a 4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban in patients with AERD. At the end of the 4-week treatment phase (ifetroban or placebo) each subject will undergo a graded oral aspirin desensitization procedure in order to initiate high-dose aspirin therapy, which is standard-of-care at our institution and is the only available therapy known to modify the course of 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of AERD, defined as meeting the diagnostic triad with:
- •History of physician-diagnosed asthma and
- •History of physician-diagnosed nasal polyposis and
- •History of pathognomonic reactions aspirin or other nonselective cyclooxygenase (COX) inhibitors.
- •Stable asthma (post-bronchodilator forced expiratory volume at one second (FEV1) of ≥70%, no glucocorticoid burst for at least 2 weeks prior to Visit 1, and no hospitalizations or ER visits for asthma for at least the prior 6 months)
- •Age between 18 and 70 years
- •No current smoking (not more than one instance of smoking in the last 3 months)
- •Non-pregnant
排除标准
- •Hypersensitivity to montelukast
- •Current use of zileuton
- •History of bleeding diathesis or use of anticoagulant or antiplatelet drugs
- •Current use of any NSAIDs aside from the aspirin provided during the study
- •Current use of beta blockers
- •Use of any biologics within the last 4 months prior to initiating the study
研究组 & 干预措施
Placebo
Subjects will be randomized to receive placebo for 4 weeks.
干预措施: Placebo (Drug)
Ifetroban
Subjects will be randomized to receive ifetroban (200 mg dose per day) for 4 weeks.
干预措施: Ifetroban (Drug)
结局指标
主要结局
Provocative Dose 2 (PD2) During Aspirin Challenge
时间窗: 6 weeks from screening visit ( at visit 2)
The calculated dose of aspirin that induces an increase in the Total Nasal Symptom Score (TNSS) of 2 from the pre-aspirin challenge value, "PD2" TNSS: A higher TNSS score suggests more severe symptoms, on a scale from 0-65 PD2: A higher PD2 suggests that the patient's threshold of reactivity of aspirin was higher
次要结局
- Percentage Change From Baseline of FEV1 During Aspirin Challenge (Bronchoconstriction)(At Visit 2. The change in FEV1 from the morning baseline to the aspirin-induced lowest value in FEV1 during reaction to aspirin challenge later that same day.)
- Change in Chronic Disease Control by Measurement of Lung Function Through FEV1(1 month (between Visit 1 and Visit 2))
- Clinical Improvement of Chronic Disease - Sino-Nasal Outcome Test (SNOT-22) Score(1 month (between Visit 1 and Visit 2))
- Aspirin-induced Leukotriene E4 (LTE4) Levels(Visit 2. The change in LTE4 levels from the morning baseline to the aspirin-induced highest value in LTE4 during reaction to aspirin challenge that same day.)
- Fractional Exhaled Nitric Oxide (FeNO)(1 month (between Visit 1 and Visit 2))
- Change in Chronic Disease by Measurement of Asthma Control Through Asthma Control Questionnaire (ACQ) Score(1 month (between Visit 1 and Visit 2))
研究者
Elliot Israel, MD
Director of Asthma Research Center
Brigham and Women's Hospital