Asthma
Conditions
Keywords
Primary care, Asthma management, Inhaled corticosteroids, Beclomethasone dipropionate, Fluticasone propionate, Metred dose inhaler, Extra-fine hydrofluoroalkane, Chlorofluorocarbon
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).
Interventions
DRUGExtra-fine hydrofluoroalkane-beclomethasone dipropionate
Initiation of HFA-BDP (any dose) in steroid naive patients via MDI
DRUGFluticasone propionate
An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as FP via MDI
DRUGBeclomethasone dipropionate
An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as CFC-BDP via MDI
DRUGfluticasone propionate
Initiation of FP (any dose) via MDI in steroid naive patient
Initiation of CFC-BDP (any dose) via MDI in steroid naive patient
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Research in Real-Life Ltd
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 use |
| Time 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. |
| 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. |
| Use of anti-fungals | One-year | defined as incidences of definite oral candidiasis |
| 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. |
| 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) |
Countries
United Kingdom
Outcome results
None listed