Modalités de Prise en chaRge en Pratique quOTidienne d'Allergologie Des Enfants et/ou adolesCents souffranT d'Allergie Aux Acariens / Treatment Modalities in Allergist Daily Practice in Children and/or Adolescents Suffering From HDM Allergy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,531
- 主要终点
- HDM sublingual immunotherapy (SLIT) daily maintenance dose
研究概览
简要总结
Two-stage, prospective, observational, real-world study of HDM-SLIT-naïve children (aged 5-11) and adolescents (aged 12-17) consulting allergists or other specialist physicians in France for an HDM-induced allergy. Physician- and/or patient-reported data on clinical symptoms, sensitization, patient profiles, symptom burdens, patient-physician dialogue, HDM SLIT regimens, and effectiveness were recorded on inclusion, and then again 6 to 12 months after the prescription of an HDM SLIT solution.
The study's primary objective was to describe treatment modalities in children (aged from 5 to 11) and adolescents (aged from 12 to 17) with suspected HDM-induced AR or allergic asthma consulting an allergist or another specialist physician in France.
详细描述
Study design:
This was an observational, non-interventional, prospective, multicentre study of real-life clinical practice in France (the PROTECT study).
Allergists and other specialist physicians with expertise in allergy were each invited to recruit up to 8 paediatric patients (aged 5 to 17) consulting for an indication of HDM-induced allergy and who had not previously received HDM SLIT.
The PROTECT study a two-stage study and comprised:
- A cross-sectional analysis (performed during the inclusion visit)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Age under 5 or over
- •Patient who already received HDMs sublingual allergen immunotherapy.
- •Patient showing contra-indications to immunotherapy: immune disorder, immunodeficiency, malignancy.
- •Participation in any clinical study involving an investigational product.
结局指标
主要结局
HDM sublingual immunotherapy (SLIT) daily maintenance dose
时间窗: At the inclusion visit
Percentage of physicians who prescribed HDM SLIT at the standard dose (%)
Total duration of HDM SLIT prescription planned by the physician
时间窗: At the inclusion visit
Duration of treatment prescribed (in months)
Proportion of physicians who prescribed symptomatic medication with HDM SLIT
时间窗: At the inclusion visit
Percentage of physicians (%)
次要结局
- Proportion of patients with decrease of impact of allergic disease on their every day life(At the follow-up visit (between 6 and 12 months after the inclusion visit))
- Physicians' overall level of satisfaction with HDM SLIT(At the follow-up visit (between 6 and 12 months after the inclusion visit))
- Proportion of patients continuing their treatment with HDM SLIT after the follow-up visit(At the follow-up visit (between 6 and 12 months after the inclusion visit))
- Proportion of physicians that estimated that the patients' adherence to HDM SLIT was good(At the follow-up visit (between 6 and 12 months after the inclusion visit))
- Proportion of patients from the cross-sectional analysis which HDM sublingual Immunotherapy (SLIT) solution was prescribed by the physician(At the inclusion visit)
- Proportion of patients with symptom relief after HDM SLIT(At the follow-up visit (between 6 and 12 months after the inclusion visit))
- Overall efficacy of HDM SLIT(At follow-up visit (between 6 and 12 months after the inclusion visit))
- Proportion of patients with symptomatic medication reduction(At follow-up visit (between 6 and 12 months after the inclusion visit))
- Patient's overall level of satisfaction with HDM SLIT(At the follow-up visit (between 6 and 12 months after the inclusion visit))
- Proportion of patients experiencing a treatment related adverse event(At the follow-up visit (between 6 and 12 months after the inclusion visit))