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
Overview
- Phase
- Not Applicable
- Intervention
- Extra-fine hydrofluoroalkane-beclomethasone dipropionate
- Conditions
- Asthma
- Sponsor
- Research in Real-Life Ltd
- Enrollment
- 815377
- Locations
- 1
- Primary Endpoint
- Proxy asthma control
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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).
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
IPDI HFA-BDP MDI
Patients who commenced inhaled corticosteroid therapy as HFA-BDP via MDI
Intervention: Extra-fine hydrofluoroalkane-beclomethasone dipropionate
IPDI FP MDI
Patients who commenced inhaled corticosteroid therapy as FP via MDI
Intervention: fluticasone propionate
IPDA FP MDI
Patients who had a step up in inhaled corticosteroid therapy as FP via MDI
Intervention: fluticasone propionate
IPDA HFA-BDP MDI
Patients who had a step up in inhaled corticosteroid therapy as HFA-BDP via MDI
Intervention: Extra-fine hydrofluoroalkane-beclomethasone dipropionate
IPDI CFC-BDP MDI
Patients who commenced inhaled corticosteroid therapy as CFC-BDP via MDI
Intervention: Chlorofluorocarbon beclomethasone dipropionate
IPDA CFC-BDP MDI
Patients who had a step up in inhaled corticosteroid therapy as CFC-BDP via MDI
Intervention: Beclomethasone dipropionate
Outcomes
Primary Outcomes
Proxy asthma control
Time Frame: 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.
Secondary Outcomes
- 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)