Effectiveness and Cost-effectiveness Evaluation of Easyhaler Versus Other Devices in a Real World Primary Care Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24,003
- 主要终点
- asthma control (excluding SABA usage)
研究概览
简要总结
The aim of this study is to compare the clinical effectiveness and cost-effectiveness of the Easyhaler® (EH) device and other DPI devices commonly used in the UK in a UK primary care asthma population of patients aged 6 to 80 years.
详细描述
A recent observational study by Price et al carried out using the UK's General Practice Research Database (CPRD) to compare asthma-related outcomes for different inhaled corticosteroid (ICS) inhaler devices, using Easyhaler and dry powder inhalers (DPIs).
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
- 6 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must also meet the following inclusion criteria:
- •(1) Aged: 6-80 years - stratified 6-11 years; 12-60 years; ≥61 years to allow paediatrics and adolescent / adult sub analyses; and to allow for the exclusion of elderly (aged 61+) smokers and ex-smokers if required.
- •(2) On-going asthma therapy: ≥2 prescriptions for asthma during the outcome period (i.e. ≥1 prescription (for any asthma therapy) in addition to the prescription for ICS at IPD (initiation / step-up/ switch).
- •(3) Evidence of active asthma:
- •Initiation - a diagnostic code for asthma
- •Step-up / Switch - ≥2 prescriptions for asthma (at least one of which is for ICS) at different points in time during the baseline year PLUS a diagnostic code for asthma.
- •(4) Have at least one year of up-to-standard (UTS) baseline data and at least one year of UTS outcome data (following the IPD).
排除标准
- •Patients will be excluded from the analysis if they have:
- •(1) Had a COPD read code at any time; and/or
- •(2) Had any chronic respiratory disease, except asthma, at any time; and/or
- •(3) Patients on maintenance oral steroids during baseline year; and/or
- •(4) Multiple ICS prescriptions at IPD.
结局指标
主要结局
asthma control (excluding SABA usage)
时间窗: 1 year
The Composite proxy for asthma control (excluding SABA usage) during the one-year outcome period, which is defined as: Controlled: the absence of the following during the one-year outcome period: (i) Asthma-related : 1. Hospital attendance or admission 2. A\&E attendance, OR 3. Out of hours attendance, OR 4. Out-patient department attendance (ii) GP consultations for lower respiratory tract infection (iii) Prescriptions for acute courses of oral steroids ; Uncontrolled: all others.
exacerbations (ATS definition)
时间窗: 1 year
Total number of asthma exacerbations (ATS Definition) defined as an occurrence of: (i) Asthma-related: 1. Hospital attendance / admissions OR 2. A\&E attendance (ii) Use of acute oral steroids.
exacerbations (Clinical definition)
时间窗: 1 year
Total number of asthma exacerbations (Clinical Definition) defined as an occurrence of: (i) Asthma-related: 1. Hospital attendance / admissions, OR 2. A\&E attendance, OR (ii) GP consultations for lower respiratory related tract infections (iii) Use of acute oral steroids.
asthma control (including SABA usage)
时间窗: 1 year
The Composite proxy for asthma control (including SABA usage) during the one-year outcome period, which is defined as: Controlled: the absence of the following during the one-year outcome period: (iv) Asthma-related : 1. Hospital attendance or admission 2. A\&E attendance, OR 3. Out of hours attendance, OR 4. Out-patient department attendance (v) GP consultations for lower respiratory tract infection (vi) Prescriptions for acute courses of oral steroids ; Plus: (vii) Average prescribed daily dose ≤200mg of Salbutamol / ≤500mg of terbutaline. Uncontrolled: all others.
次要结局
- treatment success definition 1(1 year)
- SABA dosages(1 year)
- adherence to ICS therapy(1 year)
- Medication Possession Ratio (MPR)(1 year)
- Treatment success (definition 2)(1 year)