Documentation of Efficacy of Intralymphatic Allergen Immunotherapy in a Phase III Randomized, Parallel Group Placebo Controlled Double Blind Multisite Field Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Combined symptom and medication score, cSMS
研究概览
简要总结
Investigation of the clinical efficacy of 3 intralymphatic injections with grass pollen extract into inguinal lymph nodes on combined symptom-medication scores during grass pollen season in grass pollen allergic patients compared to placebo
详细描述
A double-blind, parallel group, placebo controlled multi-site trial of the clinical efficacy of 3 intralymphatic injections with a low dose of grass pollen extract into inguinal lymph nodes in grass pollen allergic subjects.
Primary endpoint is the difference in combined symptom and medication score during grass pollen seasons following treatment compared with patients receiving placebo.
Injections are giving ultrasound-guided with at least 4 weeks intervals.
To increase trial retention, two studies within the trial are conducted: a feasibility study assessing the acceptability and feasibility of a digital intervention and its evaluation design. Outcomes include participant and stakeholder acceptability, reach, mechanisms of change to improve trial retention, utilization, unintended effects, software functionality, recruitment and retention rates, questionnaire suitability, randomization feasibility, power for a future definitive trial, and initial efficacy signals. Additionally, an evaluation study assesses the efficacy of the intervention.
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)
盲法说明
The study is run in a double-blind design
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate-severe grass pollen allergic rhinoconjunctivitis
- •positive skin prick test for grass pollen extract
排除标准
- •significant mugwort allergy
- •previous AIT for grass pollen allergy
- •uncontrolled non-allergic upper airways disease
- •uncontrolled asthma
- •planned depot steroid injections during season
- •uncontrolled autoimmune diseases
- •active malignancies
- •uncontrolled other severe condition, including psychiatric diseases
研究组 & 干预措施
grass pollen extract treatment
participants receive 3 injections with Alutard phleum pratense, ALK, grass pollen extract
干预措施: Grass pollen extract - Alutard Phleum pratense, ALK (Drug)
Placebo
Participants receive 3 injections with saline (NaCl 0.9%)
干预措施: Grass pollen extract - Alutard Phleum pratense, ALK (Drug)
结局指标
主要结局
Combined symptom and medication score, cSMS
时间窗: 2 years
daily combined symptom and medication scores during grass pollen seasons in 2022 and 2023 as compared to placebo. cSMS is a combined score of a symptom score, 0-3, where 0 indicates no symptoms and 3 indicates severe symptoms and meddication score 0-3 according to the us of reliever medication: 0: no medication, 1: antihistamine use, 2: local steroid use, 3: systemic steroid use. This results in a score ranging from 0 (no symptoms, no need for medications) to 6 (severe symptoms and need for maximum reliever medication
次要结局
- correlation of CSMS to pollen count(2 years)
- combined symptom and medication score, cSMS(2 years)
- Airwave oscillometry system(AOS), asthma(2 years)
- side-effects(3 months)
- Rhinitis related quality of life, RQLQ(2 years)
研究者
Johannes Martin Schmid
Consultant, MD, PhD
Aarhus University Hospital