Comparative Effectiveness of Extrafine Hydrofluoroalkane Beclometasone Versus Fluticasone in Paediatric Patients - a Retrospective, Real-life Observational Study in a uk Primary Care Asthma Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,654
- 主要终点
- Proxy risk domain asthma control
研究概览
简要总结
The primary aim of this study was to compare the absolute and relative effectiveness of asthma management in paediatric patients in the UK on inhaled corticosteroid (ICS) maintenance therapy as extra-fine HFA-BDP (Qvar®) pressurised metered dose inhaler (pMDI) compared with fluticasone propionate (FP) pMDI.
详细描述
Comparison of asthma control with extrafine-particle hydrofluoroalkane-beclometasone (EF HFA-BDP) vs fluticasone propionate (FP) in paediatric patients (5-11year olds). Patients identified from the General Practice Research Database (GPRD) and the Optimum Patient Care Research Database (OPCRD). Two analyses were conducted:
- Comparison of outcomes achieved by EF HFA-BDP and FP in 5-6year old patients with those achieved in 7-11yr old patients.
- Comparison of outcomes achieved by EF HFA-BDP used with or without a spacer to those achieved by standard particle fluticasone propionate (FP) used with a spacer.
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
- 5 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged: 5-11 years
- •Evidence of asthma (diagnostic code and/or current asthma therapy);
- •Have at least one year of up-to-standard (UTS) baseline data (during which the step-up to FP/SAL occurred) and at least one year of UTS outcome data (following the IPD).
排除标准
- •Had any chronic respiratory disease, except asthma, at any time; and/or
- •Patients on maintenance oral steroids during baseline year
研究组 & 干预措施
IPDI Qvar
ICS initiation as Extra-fine hydrofluoroalkane beclometasone dipropionate
干预措施: Extra-fine hydrofluoroalkane beclometasone dipropionate (Drug)
IPDI FP
ICS initiation as fluticasone propionate
干预措施: Fluticasone propionate (Drug)
结局指标
主要结局
Proxy risk domain asthma control
时间窗: One year outcome period
Defined as the absence of the following during the one-year outcome period: 1. Asthma-related: * Hospital attendance or admission, OR * A\&E attendance, OR * Out of hours attendance, OR * Out-patient department attendance 2. GP consultations for lower respiratory tract infection 3. Prescriptions for acute courses of oral steroids .
Asthma exacerbation rate ratio
时间窗: One year outcome period
Where exacerbations are defined as an occurrence of: Defined as an occurrence of: 1. Asthma related: * Hospital admission, OR * A\&E attendance, OR 2. Use of acute oral steroids.
次要结局
- Overall asthma control(One year outcome period)
- Hospitalisation rates(One year outcome period)
- Treatment success(One year outcome period)
- Adherence to ICS therapy(One year outcome period)
- Use of short-acting beta2-agonist ("reliever") therapy(One year outcome period)