A Retrospective Evaluation of the Effectiveness and Cost-effectiveness of HFA-BDP MDI (Qvar®) Compared With CFC-BDP MDI and FP MDI Used in the Management of Asthma in a Representative UK UK Primary Care Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 815,377
- 试验地点
- 1
- 主要终点
- Proxy asthma control
研究概览
简要总结
The objective of the study was to compare the effectiveness, cost-effectiveness and direct healthcare costs of managing asthma in patients with evidence of persistent asthma, following the initiation and increased dose of inhaled corticosteroid (ICS) therapy using HFA-BDP (Qvar®) (either as initial therapy or as a step-up therapy) compared with the most commonly prescribed alternative ICS in the UK, CFC-beclometasone (BDP) and fluticasone (FP) as metered dose inhalers (MDIs). Qvar vs FP analyses were split between adults (12-60yrs) and paediatrics (5-11yrs).
详细描述
While current UK asthma guidelines are underpinned with evidence from RCTs, much of this evidence has been undertaken in patients who are not representative of the majority of the current UK asthma population. In fact it has been estimated that fewer than 10% of the patients seen in everyday clinical practice would be eligible for inclusion in such trials. The poor representation of the asthma population is due to a number of factors, such as tightly-controlled inclusion criteria for RCTs. There is therefore a need for more representative RCTs and real-life and observational studies to inform existing guidelines and help optimise asthma outcomes. A more holistic approach to respiratory research would see RCT evidence complimented by "real-life" data from pragmatic trials and observational studies.
A number of trends are emerged in asthma prescribing that warrant further investigation to ascertain their benefit to both the patient and the NHS. In particular, significant pressure exists to use the cheapest inhaler devices and formulations. An analysis of a pragmatic trial of Qvar versus standard CFC-BDP undertaken by Research in Real Life suggested that Qvar may be offer greater effectiveness in.5,6 In light of these data, the following report details the findings of a study designed to examine the effectiveness of Qvar in real-life clinical practice using the General Practice Research Database (GPRD).
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 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Included patients must:
- •aged 5-60 years
- •evidence of asthma: a diagnostic code of asthma or ≥2 prescriptions for asthma in baseline year at different points in time including one of ICS
- •on current therapy at the IPD, defined as ≥1 ICS script and ≥1 other asthma prescriptions in the 12 months prior to first change in therapy
- •had definite dosing instructions
- •have at least 1 year of up-to-standard (UTS) baseline data before IPD
- •have at least 1 year of UTS outcome data after IPD.
排除标准
- •had a diagnostic read code for chronic obstructive pulmonary disease (COPD) at any time
- •had a diagnostic read code for chronic respiratory disease at any time
- •For the therapy increase patient cohort, any patients receiving a combination inhaler in addition to their separate ICS inhaler in the year prior to IPD were also excluded.
研究组 & 干预措施
IPDI HFA-BDP MDI
Patients who commenced inhaled corticosteroid therapy as HFA-BDP via MDI
干预措施: Extra-fine hydrofluoroalkane-beclomethasone dipropionate (Drug)
IPDI FP MDI
Patients who commenced inhaled corticosteroid therapy as FP via MDI
干预措施: fluticasone propionate (Drug)
IPDA FP MDI
Patients who had a step up in inhaled corticosteroid therapy as FP via MDI
干预措施: fluticasone propionate (Drug)
IPDA HFA-BDP MDI
Patients who had a step up in inhaled corticosteroid therapy as HFA-BDP via MDI
干预措施: Extra-fine hydrofluoroalkane-beclomethasone dipropionate (Drug)
IPDI CFC-BDP MDI
Patients who commenced inhaled corticosteroid therapy as CFC-BDP via MDI
干预措施: Chlorofluorocarbon beclomethasone dipropionate (Drug)
IPDA CFC-BDP MDI
Patients who had a step up in inhaled corticosteroid therapy as CFC-BDP via MDI
干预措施: Beclomethasone dipropionate (Drug)
结局指标
主要结局
Proxy asthma control
时间窗: One-year outcome period
Primary composite measure asthma control defined as: * No recorded hospital attendance for asthma including admission, Accident \& Emergency (A\&E) attendance, out of hours attendance or Out-Patient Department (OPD) attendance, AND * No prescriptions for oral steroid, AND * No consultations, hospital admissions or A\&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics.
次要结局
- Revised asthma control(One-year outcome period)
- Disaggregated components of the primary control outcome(One-year outcome period)
- Time to the first asthma exacerbation(One-year outcome period)
- Success of the therapeutic regimen(One-year outcome period)
- Use of anti-fungals(One-year)
- Daily dose of ICS (BDP equivalent) at week 52 compared with week 0 and proportion on original dose of BDP Daily dose* of ICS (BDP equivalent) at week 52 compared with week 0 and proportion on original dose of BDP.(One-year outcome period)