Real-world Effectiveness and Cost-effectiveness of Leading Inhaled Corticosteroids in Asthma Management
- Conditions
- Asthma
- Interventions
- Drug: Extra-fine hydrofluoroalkane-beclomethasone dipropionateDrug: Chlorofluorocarbon beclomethasone dipropionate
- Registration Number
- NCT01141439
- Lead Sponsor
- Research in Real-Life Ltd
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 815377
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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description IPDA FP MDI fluticasone propionate Patients who had a step up in inhaled corticosteroid therapy as FP via MDI IPDI HFA-BDP MDI Extra-fine hydrofluoroalkane-beclomethasone dipropionate Patients who commenced inhaled corticosteroid therapy as HFA-BDP via MDI IPDI FP MDI fluticasone propionate Patients who commenced inhaled corticosteroid therapy as FP via MDI IPDA HFA-BDP MDI Extra-fine hydrofluoroalkane-beclomethasone dipropionate Patients who had a step up in inhaled corticosteroid therapy as HFA-BDP via MDI IPDI CFC-BDP MDI Chlorofluorocarbon beclomethasone dipropionate Patients who commenced inhaled corticosteroid therapy as CFC-BDP via MDI IPDA CFC-BDP MDI Beclomethasone dipropionate Patients who had a step up in inhaled corticosteroid therapy as CFC-BDP via MDI
- Primary Outcome Measures
Name Time Method Proxy asthma control 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 Outcome Measures
Name Time Method Use of anti-fungals One-year defined as incidences of definite oral candidiasis
Revised asthma control One-year outcome period A revised definition of proxy asthma control for sensitivity analysis was defined as:
* No recorded hospital attendance for asthma including admission, A\&E attendance, out of hours attendance or 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
* Average daily prescribed dose of salbutamol of no more than 200mcg and terbutaline 500mcg.Disaggregated components of the primary control outcome One-year outcome period * Hospital admissions for asthma
* Consultations and hospital attendances for LRTI requiring antibiotics
* Prescriptions for oral steroids
* SABA useTime to the first asthma exacerbation One-year outcome period Where an exacerbation is defined as:
* An occurrence of unscheduled hospital admission/A\&E attendances for asthma AND/OR
* Use of oral steroids.Success of the therapeutic regimen One-year outcome period Defined as:
* Exacerbation AND/OR
* Increase in dose of ICS AND/OR
* Change in ICS drug type AND/OR
* Change in delivery device AND/OR
* Use of additional therapy as defined by: LABAs, oral steroids, theophylline, leukotriene receptor antagonists (LTRAs)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 BDP-equivalent dose were calculated by multiplying the Qvar and FP doses by a factor of 2. The dose at week 52 was compared with that at week 0 in order to identify the proportion of original (week 0) ICS dose.
Trial Locations
- Locations (1)
General Practice Research Database
🇬🇧London, United Kingdom