Retrospective, Real-life Observational, Matched Cohort Evaluation of the Effectiveness of BDP/FOR (Fostair® 100/6) and FP/SAL (Seretide® 125) in Patients Switching From Seretide to Fostair in UK 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
- 137
- 试验地点
- 1
- 主要终点
- Exacerbation rate
研究概览
简要总结
The purpose of this study is 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.
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
- •18-60 years:
- •61-80 years who are never-smokers
- •Evidence of asthma:
- •a diagnostic code for asthma, or
- •≥2 prescriptions for asthma at different points in time during the prior year
- •Baseline FP/SAL therapy:
- •≥2 prescription for ICS/LABA therapy as FP/SAL (Seretide® 125).
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
Fostair switch cohort
Seretide patients who, at an index date, had a step down in therapy (reduction in ICS dose of ≥50%) and switch to Fostair
干预措施: Fixed-dose combination beclometasone dipropionate / formoterol (Drug)
Seretide continuation cohort
Seretide patients who, at an index date, had a step down in therapy (reduction in ICS dose of ≥50%) and continue on Seretide
干预措施: Fixed dose combination salmeterol / fluticasone (Drug)
结局指标
主要结局
Exacerbation rate
时间窗: One-year outcome period
Where an exacerbation is defined as: (i) Asthma-related 1. Hospital attendance / admissions OR 2. Accident \& Emergency (A\&E) attendance OR (ii) Use of oral steroids.
次要结局
- Exacerbation control (a composite proxy measure)(One-year outcome period)
- Treatment success 1(One-year outcome period)
- Asthma hospitalisations(One-year outcome period)
- Compliance with ICS/LABA therapy(One-year outcome period)
- Use of reliever medication(One-year outcome period)
- Cost of therapeutic regimen.(One-year outcome period)
- Asthma-related / respiratory hospitalisations(one year outcome period)
- Oral Thrush(One-year outcome period)
研究者
Alison Chisholm
David Price
Research in Real-Life Ltd