A Double-blinded Placebo-controlled Randomized Clinical Trial Evaluating the Efficacy and Adverse Effect of Intralymphatic Immunotherapy (ILIT) for House Dust Mite, Cat, and Dog Allergen in Allergic Rhinitis Patients
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Rhinoconjunctivitis Quality of Life Questionnaire
研究概览
简要总结
We will perform double-blinded placebo-controlled randomized clinical trial which evaluates the efficacy and safety of allergen-specific intralymphatic immunotherapy (ILIT) for allergens including Dermatophagoides farinae (Df), Dermatophagoides pteronyssinus (Dp), cat, and dog that are sensitized and provoke rhinitis-related symptoms in patients with allergic rhinitis.
详细描述
After informed consent, subjects will be randomly assigned to ILIT group or placebo group in double-blind manner. In both group, causal allergen or placebo will be injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval. In ILIT group, initial dose of allergen will be 1,000-fold diluted solution from maximal concentration of allergen extract for subcutaneous immunotherapy (30 AU/ml for Df or Dp, 10 AU/ml for Cat hair, and 1:1/10 weight/volume for dog hair/dander, HollisterStier, New Orleans, USA) in volume of 0.1ml. If skin is highly reactive in skin prick test, the initial dose will be 10-fold dilution from maximal concentration where diameter of wheal is less than that of histamine. After the first dose, allergen concentration will be escalated 3-fold at second dose, and 10-fold at third dose if there are no local or systemic hypersensitivity reaction. The allergen concentration will not change at second or third dose if there is mild local or systemic reaction. The allergen concentration will decrease by 10 or 100-fold from previous concentration or further injection will be holded if there is severe local or systemic reaction after sufficient explanation and discussion with subjects.
The investigators will evaluate allergic rhinitis symptom score before and 4, 12 months after the initial treatment. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and Sino-Nasal Outcome Test (SNOT-20) will be used. Visual analogue scale (VAS) of symptoms including rhinorrhea, sneezing, nasal obstruction, postnasal drip, eye/nose/ear/palate itching, dyspnea, wheezing, chest discomfort as well as urticaria, angioedema, and itching on exposed skin during exposure to causal allergen in daily life will be also evaluated. Skin prick test, intradermal test, blood sampling for serum allergen-specific IgE, exhaled nitric oxide, and nasal lavage for Th1, Th2, and Treg cytokines will be also performed before and 4, 12 months after the initial treatment.
Adverse events will be recorded and graded according to Muller classification and Ring and Messner classification.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allergic rhinitis to house dust mite (Df, Dp), cat or dog
- •More than 3mm reaction at skin prick test for Df, Dp, cat or dog or more than class 3 at serum specific IgE level (UNICAP or MAST)
排除标准
- •Uncontrolled or severe asthma according to Global Initiative of Asthma (GINA) guideline
- •FEV1 less than 50% of predicted value if there is comorbid asthma.
- •Subject rejects the enrollment into study
- •Low compliance
- •Pregnancy or lactation
- •Significant cardiovascular, hepatic, renal, hematologic, oncologic, or infectious diseases
- •Administration of beta blocker, angiotensin converting enzyme inhibitor, tricyclic antidepressant, immnosuppressant including systemic glucocorticosteroid (20mg or more dose of prednisolone or equivalent dose of other steroid) within last 2 weeks
- •Prior history of allergen-specific immunotherapy
- •Allergic rhinitis caused by other perennial or seasonal allergen
- •Vulnerable volunteer
研究组 & 干预措施
Allergen extract
0.1 ml of allergen extracts
干预措施: HollisterStier (Drug)
Placebo
Normal saline, 0.1 ml
干预措施: Normal saline (Drug)
结局指标
主要结局
Rhinoconjunctivitis Quality of Life Questionnaire
时间窗: up to 12 months after the initial treatment
次要结局
- SNOT-20(before and 4, 12 months after the initial treatment)
- Nasal reactivity(before and 4, 12 months after the initial treatment)
- Exhaled NO(before and 4, 12 months after the initial treatment)
- Serum alllergen-specific IgE level(before and 4, 12 months after the initial treatment)
- Skin reactivity(before and 4, 12 months after the initial treatment)
- Cytokines in nasal lavage fluid(before and 4, 12 months after the initial treatment)
- Allergic rhinitis symptoms during allergen exposure in daily life(before and 4, 12 months after the initial treatment)
研究者
Sang Min Lee
Assistant professor of Division of Pulmonology and Allergy
Gachon University Gil Medical Center