NCT07412990招募中不适用
Eine Prospektive, Offene, Multizentrische, Nicht-interventionelle Studie Zur Erhebung Von Daten Zur Anwendung Von Grass MATA MPL 27 600 SU Und Compliance in Der täglichen Klinischen Praxis Bei Erwachsenen Gräserpollen- Allergikern
Allergy Therapeutics1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2026年3月11日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Treatment adherence
研究概览
简要总结
Objective of this non-interventional study (NIS) is to collect data on the use of Grassmuno® in routine clinical practice.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At the physician's discretion and based on the current Summary of Product Characteristics (SmPC), study participation may be offered to patients who
- •are male and female patients
- •are 18 years of age or older
- •treated in accordance with the SmPC of Grassmuno® for IgE-mediated moderate to severe allergic rhinitis and/or rhinoconjunctivitis (without asthma or with well-controlled asthma) triggered by grass pollen.
- •Patients will only be enrolled in the study after the treatment decision has been made
排除标准
- •At the physician's discretion, the study should not be offered to the following patients:
- •Patients who are not sufficiently proficient in or do not adequately understand the German language, as this would prevent adequate comprehension of study-relevant documents.
- •In addition, patients should not be included if any of the contraindications listed in the current Summary of Product Characteristics (SmPC) are present.
研究组 & 干预措施
Grass Allergic adults
Adult patients aged ≥ 18 for whom pre-seasonal subcutaneous allergen immunotherapy (AIT) with Grassmuno ® is indicated for the treatment of IgE-mediated moderate to severe allergic rhinitis and/or rhinoconjunctivitis with no asthma or with well-controlled asthma elicited by grass pollen allergy
干预措施: Grassmuno® (Drug)
结局指标
主要结局
Treatment adherence
时间窗: once a year for one year
Absolute number and percentage of treatment adherent patients after the first treatment year
次要结局
- Injection intervals(~6 injection visits (visit 1 to visit 6) per treatment year)
- Treatment adherence(once for a year for 2 years)
- Combined symptom and medication score (CSMS)(once a year for 2 years)
- Medications Score (dMS)(once a year for 2 years)
- Symptom Score (dSS)(once a year for two years)
- Rhinitis Quality of Life(three times a year (fist year), twice for 2nd year)
- Rhinitis and Rhinoconjunctivitis Score(once in two years)
- Patient Satisfaction(once a year for two years)
- Physican Satisfaction(once a year for two years)
- Incidence of Treatment-emergent adverse events (safety and tolerability)(all year for two years)
研究者
研究点 (1)
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