Is Intralymphatic Allergen Immunotherapy Effective and Safe: a Human Randomized Clinical Trial- Substudy Borås With a Randomized Preseasonal Booster
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in the serum-level of timothy specific IgG4 after 1 month
研究概览
简要总结
15 patients with moderate to severe allergic rhinitis against grass were recruited and enrolled in the study. They received three open label intralympatic grass allergen injections with the dose 1000 SQ-U each and with one month interval. The next year the patients were randomized double blind to an active or placebo booster injection of 1000 SQ-U before the pollen season. Grass specific IgG4 levels were measured before and at various time ponts after treatment.
详细描述
The purpose of the study is to evaluate whether intralymphatic administration of AIT is a safe and effective treatment for patients with pollen-induced allergic rhinitis. The long term goal is to provide a base for a more efficient administration of ASIT, which will reduce both the dose necessary and the number of clinic visits associated with the conventional subcutaneous ASIT.
The aim of the present substudy is to evaluate if a randomized preseasonal ILIT booster, after three open label ILIT injections, can increase the allergen specific IgG4 antibodies, and if the IgG4 increase can be correlated to clinical effect characterized with seasonal questionnaires.
The first part of the study is completed and published (PMID: 23374268)
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-50,
- •Seasonal allergic symptoms for birch and/or grass verified by skin prick test,
- •Accepted informed consent
排除标准
- •Pregnancy or nursing
- •Autoimmune or collagen disease (known)
- •Cardiovascular disease
- •Perennial pulmonary disease
- •Hepatic disease
- •Renal disease
- •Any medication with a possible side-effect of interfering with the immune response
- •Previous immuno- or chemotherapy
- •Chronic diseases
- •Other upper airway disease (non-allergic sinusitis, nasal polyps, chronic obstructive and restrictive lung disease)
- •Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with β-blockers)
- •Major metabolic disease
- •Known or suspected allergy to the study product
- •Alcohol or drug abuse
- •Mental incapability of coping with the study
- •Withdrawal of informed consent
研究组 & 干预措施
Placebo booster
After three basic open label grass allergen ILIT injections the patient is randomized to a placebo ILIT booster 1 year after the first treatment.
干预措施: ALK Diluent (Drug)
Active booster
After three basic open label grass allergen ILIT injections the patient is randomized to an active ILIT booster 1 year after the first treatment.
干预措施: ALK Alutard 5-grasses (Drug)
结局指标
主要结局
Change in the serum-level of timothy specific IgG4 after 1 month
时间窗: Change between baseline and 1 month after treatment.
Blood samples with measurement of allergen specific blocking IgG4 antibodies
Change in the serum-level of timothy specific IgG4 after 9 months
时间窗: Change between baseline and 9 months after treatment.
Blood samples with measurement of allergen specific blocking IgG4 antibodies
Change in the serum-level of timothy specific IgG4 2 months after booster
时间窗: Change between baseline and 2 months after the booster treatment (14 months after the basic treatment).
Blood samples with measurement of allergen specific blocking IgG4 antibodies
Change in the serum-level of timothy specific IgG4 10 months after booster
时间窗: Change between baseline and 10 months after the booster treatment (22 months after the basic treatment).
Blood samples with measurement of allergen specific blocking IgG4 antibodies
次要结局
未报告次要终点
研究者
Lars Olaf Cardell
Professor
Karolinska Institutet