Molecular Allergen Based Diagnosis Impact on Clinical Efficacy of Aeroallergen Immunotherapy- a Pragmatic Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Change of combined symptom and medication score (CSMS) at 52 weeks
研究概览
简要总结
Allergen immunotherapy (AIT) is used for the control of allergic diseases that are not completely responsive to avoidance strategies and/or pharmacotherapy. It is also considered the main treatment with the potential to modify allergic disease evolution. It's efficacy and safety in allergic rhinitis and asthma is supported by large systematic reviews and is recommended as a cornerstone treatment option in allergic disease. Molecular based allergy diagnosis has greatly evolved and the knowledge of molecular allergen sensitization pattern has been used to better define the allergen extract composition of AIT. However, uncertainty remains if this strategy is related to an increase of efficacy. Regulation of allergen extracts for allergen immunotherapy are currently underway in Europe, but there is still lack of standardization of relevant allergens and important differences are seen between allergenic contents.
Therefore, we aim to evaluate, in a real-life setting, the impact of using molecular-based diagnosis versus standard diagnostic tools in the efficacy of aeroallergen immunotherapy, using a pragmatic randomized controlled trial design and also to address the impact of the discrepancy between individual aeroallergen sensitization profiles and the major allergen molecular content of aeroallergen immunotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with medical indication for aeroallergen immunotherapy(AIT) for allergic rhinoconjunctivitis or asthma, accordingly to the AIT guidelines;
- •Over 5 years of age;
- •Evidence of IgE-sensitization (positive skin prick tests and / or serum specific-IgE)
- •Patients have indication to AIT to house dust mites and/or grass pollen, association with other allergens is not an exclusion criteria
排除标准
- •Previously performed allergen immunotherapy
- •Need the use of molecular allergen diagnosis to decide treatment and diagnostic strategy
结局指标
主要结局
Change of combined symptom and medication score (CSMS) at 52 weeks
时间窗: 0 to 52 weeks
Differences, in the mean change at 52 weeks, of CSMS between groups that were treated with AIT in the component resolved diagnosis versus standard diagnosis groups. CSMS is the sum of the daily symptom score (dSS, score 0 to 3) plus daily medication score (dMS; score 0 to 6)
Change of combined symptom and medication score (CSMS) at 24 weeks
时间窗: 0 to 24 weeks
Difference, in the mean change at 24 weeks, of CSMS between groups were treated with AIT in the component resolved diagnosis versus standard diagnosis groups.
Change of rhinitis symptoms using visual analogue scale at 52 weeks
时间窗: 0 to 52 weeks
Difference between groups(control vs intervention) in the mean change at 52 weeks, in the psychometric response scale. This scale is used to assess rhinoconjunctivitis discomfort and its impacts on symptom severity and need of treatment.
Change of rhinitis symptoms using visual analogue scale at 24 weeks
时间窗: 0 to 24 weeks
Difference between groups(control vs intervention) in the mean change at 52 weeks, in the psychometric response scale. This scale is used to assess rhinoconjunctivitis discomfort and its impacts on symptom severity and need of treatment.
次要结局
- Change in Control of Allergic Rhinitis and Asthma Test (CARAT) at 24 weeks(0 to 24 weeks)
- Change in Control of Allergic Rhinitis and Asthma Test (CARAT) at 52 weeks(0 to 52 weeks)
- Change in quality of life related with rhinitis and asthma at 24 weeks(0 to 24 weeks)
- Change in the cost impact between groups(0 and 52 weeks)
- Change in Asthma Control Test (ACT) at 52 weeks(0 to 52 weeks)
- Change in Asthma Control Test (ACT) at 24 weeks(0 to 24 weeks)
- Change in quality of life related with rhinitis and asthma at 52 weeks(0 to 52 weeks)
- Change in ESPIA score- patient reported opinion allergen immunotherapy at 52 weeks(0 to 52 weeks)
- Change in ESPIA score- patient reported opinion allergen immunotherapy at 24 weeks(0 to 24 weeks)