Retrospective Data Collection Based on Patient Records and Questionaire Based Data of Therapy Results of Allergen-specific Immunotherapy With Pollinex Quattro With Tree and/or Gras Pollen Extracts and Their Mixtures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Change in allergen specific IgE after allergen-specific immunotherapy
研究概览
简要总结
Primary goal of this non-interventional study is to evaluate the change in level of allergen-specific IgE (EAST class) after allergen-specific immunotherapy with Pollinex Quattro with tree and/or grass pollen extracts and their mixtures under medial routine at adults with tree- and/or grass-medicated pollinosis.
详细描述
In this non-interventional study, the change in level of allergen-specific IgE before and after 3 or more years of allergen-specific immunotherapy with Pollinex Quattro in a patient population with tree and/or grass pollen induced pollinosis and/or asthma will be analyzed. In addition, the change in medication usage, asthma status for asthmatic patients after 3, 4 or 5 years of allergen specific immunotherapy will be evaluated. Furthermore, patients will be asked for their change in quality of life after therapy end.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients ≥ 18 years
- •Diagnosis of IgE-mediated rhinitis, conjunctivitis and bronchial asthma on grass and/or tree pollen
- •completed allergen-specific immunotherapy with Pollinex Quattro with tree and/or grass pollen extracts or their mixtures according to SMPC effective during immunotherapy
排除标准
- •Contraindication according to Summary of Product Characteristics (SMPC) effective during immunotherapy
- •no additional allergen-specific immunotherapy with another product than Pollinex Quattro
研究组 & 干预措施
Adults
Patients with IgE-induced Rhinitis, Conjunctivitis and/or asthma due to tree- and/or grass pollen induced allergy
干预措施: Pollinex Quattro with tree- and grass pollen extracts and their mixtures (Drug)
结局指标
主要结局
Change in allergen specific IgE after allergen-specific immunotherapy
时间窗: baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)
Efficacy
次要结局
- Change in medication usage after allergen-specific immunotherapy(baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy))
- Change in FEV1 (forced expiratory volume at one second; measured in %) after allergen-specific immunotherapy(baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy))
- Change in lung function resistance (measured in Kpa/l/s) after allergen-specific immunotherapy(baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy))
- Assessment of allergic eye symptoms (itching, tearing, redness, feeling of pressure) , on a scale 0 -10 (none - severe) after allergen-specific immunotherapy(baseline, post-treatment, at least 3 years of allergen-specific immunotherapy)
- Assessment of allergic nasal symptoms (rhinorrhea, nasal obstruction) , on a scale 0 -10 (none - severe) after allergen-specific immunotherapy(baseline, post-treatment, at least 3 years of allergen-specific immunotherapy)
- Assessment of allergic lung/bronchial symptoms (shortness of breath, cough), on a scale 0 -10 (none - severe) after allergen-specific immunotherapy(baseline, post-treatment, at least 3 years of allergen-specific immunotherapy)