Comparative Effectiveness of Extrafine Hydrofluoroalkane Beclometasone Versus Fluticasone and Chlorofluorocarbon Beclometasone in Smoking Asthma - 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
- 7,195
- 主要终点
- Asthma Control proxy incorporating SABA use
研究概览
简要总结
To evaluate the comparative effectiveness of extrafine hydrofluoroalkane beclometasone (EF HFA-BDP) and other inhaled corticosteroid (ICS) therapy commonly used in the UK, specifically fluticasone (FP) and non-extrafine (NEF) BDP (CFC-BDP and NEF HFA-BDP) in a UK primary care asthma population of current smokers.
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
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 16-70 years
- •Current smokers - explicitly coded in patient records or captured in patient questionnaires
- •Evidence of asthma diagnosis and current therapy: ≥2 prescriptions for asthma at different points in time during the baseline year ± a diagnostic code for asthma
- •On-going asthma therapy: ≥2 prescription for ICS during the outcome period (i.e. ≥1 prescription in addition to IPD prescription)
- •≥2 years continuous data (i.e. ≥1 year of baseline plus ≥1 year of outcome data)
排除标准
- •Patients will be excluded from the analysis if they have:
- •Any chronic respiratory disease other than asthma
- •Are prescribed:
- •Maintenance oral steroid therapy during the baseline year
- •Combination ICS/long-acting beta agonist (LABA) therapy during baseline year or at IPD
- •Multiple ICS prescriptions at IPD or immediately before .
结局指标
主要结局
Asthma Control proxy incorporating SABA use
时间窗: 1 year
Where control is defined as absence of: (i)Respiratory-related: Hospital attendance or admission A\&E attendance, OR Out of hours attendance, OR Out-patient department attendance (ii)GP consultations for lower respiratory tract infection (iii)Prescriptions for acute courses of oral steroids (iv)Average prescribed daily dose of albuterol or terbutaline of ≤200mg
Asthma Exacerbations (ATS Definition)
时间窗: 1 year
Defined as an absence of the the following: 1. Asthma related hospital attendance or admission, OR A\&E attendance, OR 2. Use of acute oral steroids.
次要结局
- Exacerbation definition based on clinical experience(1 year)
- Asthma control proxy excluding SABA usage(1 year)
- Treatment Success(1 year)
- Definite asthma-related hospitalisations(1 year)
- ICS Compliance(1 year)
- Incidence of oral thrust(1 year)
- SABA Dose(1 year)
- Definite and probable asthma-related hospitalisations(1 year)
研究者
David Price
Professor David Price
Research in Real-Life Ltd