A Long-term, Prospective, Open, Multi-centre, Non-interventional Study to Evaluate the Effectiveness After Treatment With TA Bäume Top (Trees) and TA Gräser Top (Grass) Following a Perennial Posology in Children and Adults, as Well as Proofing the Non-inferiority of Children Compared to Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- change in the combined symptom medication score (CSMS)
研究概览
简要总结
The primary objective of this 5-year study is to demonstrate non-inferiority of children compared to adults by exploring long-term effectiveness after treatment with TA Bäume (trees) and TA Gräser (grass) following a perennial posology.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients from 5 years of age who are treated with TA Gräser top or TA Bäume top due to rhinitis, conjunctivitis and/or mild to moderate bronchial asthma, which are caused by an IgE-mediated allergy to grass and rye pollen or birch, alder and hazel pollen according to the respective SmPC.
- •Patients will only be included in this study after the decision on the treatment has been made.
排除标准
- •History of allergen-specific immunotherapy (SIT) for trees or grass within the last 5 years
- •If it´s intended to treat the patient with only a preseasonal therapy
- •A patient should also not be included in the presence of any of the conditions listed in the respective SmPC
研究组 & 干预措施
Adults
adult patients aged ≥ 18 with rhinitis, conjunctivitis and/or mild to moderate bronchial asthma, caused by an IgE-mediated allergy to grass/rye or tree pollen; who are treated with MATA grass or MATA trees as part of their routine medical care
干预措施: MATA trees or MATA grass (Drug)
Children
children aged from >5 to 17 years with rhinitis, conjunctivitis and/or mild to moderate bronchial asthma, caused by an IgE-mediated allergy to grass/rye or tree pollen; who are treated with MATA grass or MATA trees as part of their routine medical care
干预措施: MATA trees or MATA grass (Drug)
结局指标
主要结局
change in the combined symptom medication score (CSMS)
时间窗: once a year for 5 years
The primary endpoint is the change in the total combined symptom medication score (CSMS) during the entire study period, determined from the rhinoconjunctivitis daily symptom score (dSS) and rhinoconjunctivitis daily medication score (dMS), averaged over the respective peak pollen season
次要结局
- rhinoconjunctivitis daily medication score(once a year for 5 years)
- rhinoconjunctivitis daily symptom score(once a year for 5 years)
- Rhinoconjunctivitis Quality of Life(twice a year for 5 years)
- Rhinitis Control(twice a year for 5 years)
- Asthma Control(twice a year for 5 years)
- Incidence of Treatment-Emergent Adverse Events (safety and tolerability)(all year for 3 years)
- treatment satisfaction(once after 3 years and once after 5 years)