General Practice Research Database
London, SW8 5NQ, United Kingdom
NCT Number: NCT01141439
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).
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Notify Me5 year–60 year
All sexes
Observational
London, SW8 5NQ, United Kingdom
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Included patients must:
Exclusion criteria
Initiation of HFA-BDP (any dose) in steroid naive patients via MDI
Other names: Qvar®
An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as FP via MDI
An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as CFC-BDP via MDI
Initiation of CFC-BDP (any dose) via MDI in steroid naive patient
Time frame: One-year outcome period
Primary composite measure asthma control defined as:
Time frame: One-year outcome period
A revised definition of proxy asthma control for sensitivity analysis was defined as:
Time frame: One-year outcome period
Time frame: One-year outcome period
Where an exacerbation is defined as:
Time frame: One-year outcome period
Defined as:
Time frame: One-year
defined as incidences of definite oral candidiasis
Time frame: 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.
Research in Real-Life Ltd
Network
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
Acronym: QvarAsthma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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