Documentation of Efficacy for Intralymphatic Allergen Immunotherapy in a Phase III Randomized, Parallel Group, Double Blind Placebo-controlled Multisite Field Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Combined symptom medication score (cSMS)
研究概览
简要总结
The primary goal is to investigate the efficacy of intralymphatic immunotherapy (ILIT) for the treatment of allergic rhinitis and allergic asthma due to sensitisation to grass pollen allergens. 60 patients with allergic rhinitis will be included and randomized to receive either Polvac (n=30) or placebo (n=30). All patients will receive three injections with 4-8 weeks interval. The injections into a inguinal lymph node is guided by sonography.
Patients will record symptoms and medication use in the summer of 2022 and 2023.
详细描述
This study is part of a multicenter trial Phase III that takes place also in Denmark and Sweden (EudraCT registration number 2020-001060-28). The primary goal is to investigate the efficacy of intralymphatic immunotherapy (ILIT) for the treatment of allergic rhinitis and allergic asthma due to sensitisation to grass pollen allergens.
In the Swiss arm of trial, Polvac (Allergy Therapeutics, United Kingdom) is applied. In Denmark and Sweden, the applied drug is Alutard (ALK, Denmark). The major difference is the excipient adjuvant, which is microcrystallin tyrosine (MCT) in Polvac aluminium in Alutard. The concentration of major allergen 60 phl p5, as the active ingredient, is the same in both products. The active ingredient is a standardised grass pollen allergen extract combined with MCT. The allergen extract has been treated with glutaraldehyd as to reduce allergenicity, i.e., increase the safety. In Switzerland and Germany, Bencard AG is providing the product. Polvac™, is a marketed product that is approved by the Swiss Medical Product Agencies and adheres to GMP. The product consists of needle-like crystalline structures of average 20 micrometer size. Polvac is approved for subcutaneous immunotherapy (SCIT), which consists of 6 pre-seasonal injections with 1-2 week intervals for 3-4 years, adding up to a total of 18 to 24 injections for the treatment to be completed.
In the currents study, 60 patients with allergic rhinitis will be included and randomized to receive either Polvac (n=30) or placebo (n=30). Primary screening is done online through questionnaires. Secondary screening and inclusion is done clinical at the University Hospital Zurich. All patients will receive three injections of Polvac or placebo (saline) with 4-8 weeks interval. The injections into a inguinal lymph node is guided by sonography.
For three days post each injections, adverse events will be recorded by patients using an on line application. In the summer seasons of 2022 and of 2023, the patients will record daily allergic symptoms and daily medication usage using an online application. These record are the basics for the efficacy analysis.
Addition on January 12th 2024:
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •passed online screening with a Rhinoconjunctivitis Total Symptom Score (RTSS) value of 8 or higher.
- •sensitisation to grass pollen allergens with a skin prick test reaction to grass pollen allergen of 3 mm or more.
- •eligible to allergen immunotherapy.
- •18 years or older.
- •comfortable with digital data entry.
排除标准
- •previous grass pollen-specific immunotherapy.
- •significant allergy to mugwort or pet animal allergens.
- •uncontrolled asthma.
- •upper airway disease.
- •severe pulmonary disease.
- •recent allergic reactions.
- •immunosuppression.
- •cardiovascular disease.
- •malignant disease.
- •use of ACE-blockers.
- •other diseases or conditions rendering the treatment of anaphylactic reactions difficult.
研究组 & 干预措施
Polvac
Polvac Grass+Rye
干预措施: Polvac Grass+Rye (Biological)
Placebo
Saline
干预措施: Polvac Grass+Rye (Biological)
Placebo
Saline
干预措施: Saline 0.9% (Drug)
结局指标
主要结局
Combined symptom medication score (cSMS)
时间窗: 3 months (2 minutes per day)
Daily registration of symptoms and medication usage by the study participants and by means of a online application. This is done during the pollen season of 2022 (and possible 2023 if the 2022 season is poor with low amounts of pollen). The assessment is done over a time period, but the records are integrated for the calculation of one single score (cSMS), which is the primary outcome.
次要结局
- Asthma(10 minutes (5 times in two years))
- Biomarkers(5 minutes (8 times in two years))
- Rhino conjunctivitis quality of life score (RQLQ)(3 months (10 minutes per week))
- Lower airway disease(10 minutes (5 times in two years))
研究者
Pal Johansen
Professor Dr. sc.
University of Zurich