Phase 1 Single Center, Randomized, Controlled Study Using Sublingual Immunotherapy for Timothy Grass and Dust Mite Allergies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Primary Outcome is safety
研究概览
简要总结
This is a study for children and adults who are interested in a new therapy for their allergies to dust mite and timothy grass. The new therapy is called sublingual immunotherapy and the investigators are testing if it is safe and well tolerated.
详细描述
This is a phase I, single-center, randomized, placebo-controlled study of sublingual immunotherapy (SLIT) in pediatric and adult subjects with both house dust mite (HDM) and timothy grass (TG) allergies. We will evaluate whether Dermatophagoides farinae (DF) and/or TG allergen SLIT is safe in children and adults. We will also determine whether treatment with DF and/or TG SLIT reduces the severity of allergic symptoms (allergic rhinitis, allergic conjunctivitis) and enhances their resolution. The study will also evaluate whether SLIT provides a robust durability of response once it is terminated. The dosing-phase of the study will last up to 12 months. In addition, a follow up period of 2 years will occur. Approximately 10 subjects will be on placebo, and 20 on active treatment.
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
- 5 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sublingual immunotherapy
Subjects will take sublingual immunotherapy who have dust mite and timothy grass allergies
干预措施: sublingual immunotherapy (Drug)
placebo arm
The placebo arm will be double blinded and is an important control in SLIT therapies
干预措施: sublingual immunotherapy (Drug)
placebo arm
The placebo arm will be double blinded and is an important control in SLIT therapies
干预措施: placebo sublingual immunotherapy (Drug)
结局指标
主要结局
Primary Outcome is safety
时间窗: 2008-2014 (6 years)
We will assess safety outcomes according to GCP/CFR and NIAID guidelines
The number of adverse events in the placebo vs the treatment arm will be compared
时间窗: 2008-2016
Adverse events will be defined by GCP/CFR and by NIAID guidelines.
次要结局
未报告次要终点
研究者
Kari Christine Nadeau
Principle Investigator
Stanford University
