Adding Biological Therapy to Asthmatic Patients on Allergen Immunotherapy to House Dust Mites
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Assess the effectiveness of combined therapy : omalizumab+ immunotherapy
研究概览
简要总结
Most current studies involve using a biological drug to increase the safety of allergen immunotherapy (AIT) especially in the treatment of food allergies, to avoid the risk of anaphylaxis. However, adding Xolair® to AIT may improve the therapy's effectiveness. There are still few observations on this topic, especially in patients with house dust mite (HDM)-driven asthma.
详细描述
Assess the effectiveness of combined therapy Actair® plus Xolair compared to monotherapy with Actair® or Xolair® or standard symptomatic therapy in patients with mild or moderate allergic asthma to HDM.
Treatment duration: 24 months Follow-up duration:12 months Total duration: 36 months (not including screening and randomization period) May 2024 - March 2028 Consisting of a 4 to 5 months screening phase (with 1 month observation period prior to randomization) a treatment phase of 24 months and post-treatment follow-up phase 12 months
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
- None
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
- •>18 years old
- •A total IgE between 30-700 IU/mL
- •Moderate asthma with perennial symptoms confirmed as HDM-driven asthma based on medical history and positive nasal provocation tests, partially controlled asthma;
- •FEV1 >70% at baseline;
- •Positive skin prick test results for D. pteronyssinus, D. farinae
排除标准
- •Sensitisation to other allergens with clinical signs not related to HDM
- •Uncontrolled asthma,
- •Other serious diseases or chronic unstable diseases
- •Allergen immunotherapy during the past 5 years
- •Contraindicating allergen immunotherapy and omalizumab treatment.
结局指标
主要结局
Assess the effectiveness of combined therapy : omalizumab+ immunotherapy
时间窗: 3 years
Daily dose of inhaled steroids (changes)
次要结局
未报告次要终点