REACH Fostair vs Seretide - Real-world Effectiveness of Combination Therapies in Primary Care Asthma Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 194,723
- 主要终点
- Exacerbations : rate ratio
研究概览
简要总结
To evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol (FP/SAL; Seretide® 125) in matched asthma patients switching to BDP/FOR following treatment with FP/SAL in normal clinical practice compared with patients not switched.
详细描述
To evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol (FP/SAL; Seretide®) in matched asthma patients switching to BDP/FOR following treatment with FP/SAL in normal clinical practice compared with patients not switched. To evaluate respiratory outcomes for Fostair in comparison to Seretide using a UK primary care database (in patients switched for cost rather than clinical reasons).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged: 18-80 years 61-80 years to be non-smokers only
- •Evidence of asthma: a diagnostic code for asthma or two scripts for asthma..
- •Baseline FP/SAL therapy: ≥2 prescription for ICS/LABA therapy as FP/SAL
- •Evidence of Continuing Therapy: Include only patients who receive ≥2 prescriptions for the therapy under study during the outcome year (i.e. ≥1 prescription at the index date and ≥1 other). UK average is 3-4 prescriptions refilled per year, so ≥2 ensures capture of "real-life" data.
- •Evidence of Switching for economic reasons: FP/SAL patients from practices with ≥5 switches to Fostair in a 3 month period to minimise data taken from switching of anomalous patients; optimal practices for inclusion are those switching "wholesale" for economic reasons.
排除标准
- •Any chronic respiratory disease other than asthma
- •Are receiving maintenance oral steroid therapy during baseline period
研究组 & 干预措施
FP/SAL
Patients receiving ICS/LABA therapy as FP/SAL (Seretide®) who, at an index prescription date (IPD) : Remain on FP/SAL at the same BDP-equivalent ICS dose
干预措施: FP/SAL (Drug)
BDP/FOR
Patients receiving ICS/LABA therapy as FP/SAL (Seretide®) who, at an index prescription date (IPD): Change their therapy to BDP/FOR (Fostair®) at same or lower BDP-equivalent ICS dose
干预措施: FP/SAL (Drug)
BDP/FOR
Patients receiving ICS/LABA therapy as FP/SAL (Seretide®) who, at an index prescription date (IPD): Change their therapy to BDP/FOR (Fostair®) at same or lower BDP-equivalent ICS dose
干预措施: BDP/FOR (Drug)
结局指标
主要结局
Exacerbations : rate ratio
时间窗: 1 year
Where an exacerbation is defined as: (i) Asthma-related 1. Hospital attendance / admissions OR 2. Accident \& Emergency (A\&E) attendance OR (ii) Use of acute oral steroids. Where: * ≥1 oral steroid prescription occurs within 2 weeks of another, or * ≥1 hospitalisation occurs within 2 weeks of another, or * ≥1 hospitalisation occurs within 2 weeks of an oral steroid prescription
次要结局
- Treatment success(1 year)
- Hospitalisations(1 year)
- Asthma Control (including SABA)(1 year)
- Medication possession ratio(1 year)
- Exacerbation control(1 year)
- Proxy asthma control + SABA(1 year)
研究者
David Price, Prof., MD
Professor David Price
Research in Real-Life Ltd