Intralymphatic Immunotherapy in Increasing Doses up to 10 000 SQ-U - a Human Randomized Clinical Trial. Substudy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Mean combined daily symptoms-and-medications-score
研究概览
简要总结
The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy in increasing doses. Patients with allergy to grass or birch will be treated with three intralymphatic injections in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or placebo.
***IMPORTANT INFORMATION!*** The up-dosing protocol is changed due to adverse events at 5000 SQ-U. One patient had general utricaria 15 minutes after injection (moderate reaction). One patient had a serious adverse event with anaphylactic reaction 6 minutes after intralymphatic injection. (1000 SQ-U and 3000 SQ-U have been given with no serious adverse events.) New regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U.
详细描述
40 patients with seasonal allergic rhinitis will be recruited. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch. Injections are given with 4-5 (-7) weeks interval.
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
- •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
Intralymphatic placebo injections
ALK Diluent, ATC-code V07AB. 3 injections with 4-7 weeks interval.
干预措施: ALK Diluent (Drug)
Intralymphatic active injections
ATC-code V01AA02. 3 injections with 4-7 weeks interval in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U, 10000 SQ-U.
***IMPORTANT INFORMATION! The up-dosing protocol is changed due to an adverse event at the last injection. New regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U. ***
干预措施: ALK Alutard SQ 5-grasses or ALK Alutard Birch (Drug)
结局指标
主要结局
Mean combined daily symptoms-and-medications-score
时间窗: Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).
Daily scoring of rhinoconjunctivitis symptoms (6 questions, 4-point scale) and medication use (oral or topical antihistamines, intranasal corticosteroids, oral corticosteroids).
次要结局
- Mean total daily symptoms score(Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).)
- Mean total daily medications score(Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).)
- Change in subjective allergic symptoms following nasal allergen provocation(Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment.)
- Effects on quality of life(During peak pollen season which will be up to 6 months after completed treatment.)
- Registration of adverse event(From the first injection to 30 days after the last injections has been given)
- Short term change of skin reactivity(Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment.)
- S-IgE Grass or Birch(Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment)
- S-IgG4 Grass or 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, M.D.
Karolinska Institutet