Intralymphatic Allergen-specific Immunity as a New Administration Route for Treatment of Pollen-induced Allergic Diseases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in subjective allergic symptoms following nasal allergen provocation
研究概览
简要总结
Allergen-specific immunotherapy (ASIT) is commonly used to treat patients with allergic rhino-conjunctivitis and asthma, and it is the only proven treatment that affects the long-term development of allergic rhinitis and asthma. The current treatment regime of ASIT requires numerous subcutaneous allergen injections and takes several years to complete. Hence, there is a need to develop more convenient protocols for induction of allergen tolerance.
Emerging evidence suggest that by targeting of antigen presenting cells within the lymph nodes the immunogenicity of the allergen can be enhanced and the number of injections can be reduced.
The purpose of this study is to evaluate whether intralymphatic administration of ASIT 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 investigators will make an attempt to reproduce the results of a recent human study of intralymphatic ASIT (clinicaltrials.gov; NCT00470457) in a Swedish clinical setting.
The first part of the study is completed and published (PMID: 23374268)
详细描述
In the first part of the study safety and clinical efficacy of ALK Alutard Birch or 5-grass have been evaluated in a RCT with 50 patients. Active patients recieve 3 injections with 1000 SQ-U ALK Alutard or 5-grasses in a lymph node in the groin. Dose interval 4 weeks. This part of the study is completed and published (PMID: 23374268)
In the second part of the study 60 patients participates in a RCT with intralymphatic injections with both ALK Alutard Birch AND ALK Alutard 5-grasses. The injections are given intralymphatically with one allergen in each groin with 30 minutes observation between injections. Dose and dose interval are the same as in the first part of the study; the active group recieves 1000 SQ-U ALK Alutard Birch in right groin and 1000 SQ-U 5-grasses in left groin. The injections are given 3 times with 4 weeks interval. Enrollment and treatment is completed and the results will be evaluated in the autumn 2015.
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 50 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
ALK Alutard Birch and/or 5-grasses
3 intralymphatic injections with dose 1000 SQ-U and dose interval 4 weeks.
干预措施: ALK Alutard Birch and/or 5-grasses (Drug)
ALK diluent
3 intralymphatic injections with dose interval 4 weeks.
干预措施: ALK Diluent (Drug)
结局指标
主要结局
Change in subjective allergic symptoms following nasal allergen provocation
时间窗: Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment.
The study subjects will be intranasally challenged with allergen and symptom score questionnaires are filled out pre-provocation and 5, 10 and 30 min post-provocation.
次要结局
- Effects on quality of life(During peak pollen season which will be up to 5 months (birch) and 6 months (grass) after completed treatment)
- Change in symptoms at pollen season(6-9 months after treatment.)
- Registration of adverse event(from the first injection to 30 days after the last injections has been given)
- Change in medicine consumption during pollen season(6-9 months after treatment.)
- S-IgE Birch(Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment)
- Short term improvement of skin reactivity(Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment.)
- S-IgE Grass(Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment)
- S-IgG4 Grass(Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment)
- S-IgG4 Birch(Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment)
研究者
Lars Olaf Cardell
Professor, Head of Division, MD
Karolinska Institutet