Dupilumab as add-on Therapy for Aspirin-exacerbated Respiratory Disease (AERD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- SNOT 22 Score
研究概览
简要总结
Subjects with physician-diagnosed aspirin-exacerbated respiratory disease (AERD) who remain unacceptably symptomatic with a SNOT 22 score > 18 despite routine medical therapy will be enrolled in this single center, single-blinded study assessing the efficacy of dupilumab in AERD.
详细描述
This is a single blind, placebo controlled trial to be conducted in adult patients with AERD to determine the efficacy and safety of dupilumab in treating symptoms of chronic rhinosinusitis.
All subjects will be treated with the FDA-approved and the commercially available dose for adult atopic dermatitis of 300 mg every 2 weeks administered subcutaneously, based on the observed efficacy and safety of this dose. In addition to atopic dermatitis, this dose has also been shown to be efficacious in adult asthma.15 Patients will not be treated with a loading dose since other studies of dupilumab in asthma and chronic rhinosinusitis with nasal polyposis have not used a loading dose.
There will be a one month screening period to determine the patient's eligibility and establish symptom control and baseline parameters.
Patients will continue their background medications for chronic rhinosinusitis with nasal polyposis and asthma. These medications may include nasal corticosteroids, nasal antihistamines, systemic antihistamines, leukotriene receptor antagonists, 5 lipo-oxygenase inhibitors, inhaled corticosteroids, long-acting beta agonists, and long acting muscarinic antagonists. These controller medications will not be dispensed or supplied by the sponsor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 18 years and older with a physician diagnosis of aspirin-exacerbated respiratory disease, as defined by a physician diagnosis of asthma, chronic rhinosinusitis with nasal polyposis, and a convincing clinical history of NSAID sensitivity
- •All subjects must have a SNOT 22 score ≥ 19 despite standard medical therapy. This minimal SNOT 22 was calculated by taking the range of SNOT 22 scores in studies of normal controls plus 8.9, which is the minimal clinically meaningful improvement in SNOT 22 score detected by patients.
- •Able to understand and willingness to sign informed consent
- •Able to comply with study procedures
排除标准
- •Patient < 18 years of age
- •Pregnancy or breast feeding
- •Current tobacco use
- •Significant, uncontrolled medical conditions
- •Ongoing malignancy or history of malignancy in remission within the past 12 months
- •Current treatment with immunosuppressive medications except chronic oral steroids
- •Currently increasing dose of aeroallergen immunotherapy (patients on stable dose of aeroallergen immunotherapy will be allowed to participate)
- •Treatment with omalizumab, reslizumab, mepolizumab within 4 months of enrollment
研究组 & 干预措施
Treatment arm
Single-blinded, Dupilumab or matching placebo will be administered to the patients at the study visits. At each study visit, a single dose of dupilumab or placebo will be dispensed to the patients to be administered at home.
300 mg/2 ml solution in a single-dose pre-filled syringe with needle shield given once every 2 weeks in a subcutaneous injection
干预措施: Dupilumab (Drug)
结局指标
主要结局
SNOT 22 Score
时间窗: From baseline to completion of study(7 months total)
This is a patient-reported outcome score for chronic rhinosinusitis with or without nasal polyposis
次要结局
- Serum tryptase(From baseline to completion of study( 7 months total))
- Eosinophil count(From baseline to completion of study( 7 months total))
- UPSIT(From baseline to completion of study( 7 months total))
- Lund Mackay score(From baseline to completion of study( 7 months total))
- ACT score(From baseline to completion of study( 7 months total))
- Asthma Mini-AQLQ, 15 questions to assess quality of life. This assessment takes approximately 4-5 minutes to complete the questions.(From baseline to completion of study( 7 months total))
- Change in FEV1(From baseline to completion of study( 7 months total))
- Change in FeNO(From baseline to completion of study( 7 months total))
- Total serum IgE(From baseline to completion of study( 7 months total))
- Serum prostaglandin D2(From baseline to completion of study( 7 months total))
- To assess the safety and tolerability of dupilumab(From baseline to completion of study( 7 months total))
- To assess cumulative dose of systemic steroids(From baseline to completion of study( 7 months total))
- Serum TARC (thymus and activation regulated cytokine)(From baseline to completion of study( 7 months total))
- 24 hour urinary leukotriene E4(From baseline to completion of study( 7 months total))
研究者
S. Shahzad Mustafa
Principle Investigator
Rochester General Hospital