NCT01141439

Real-world Effectiveness and Cost-effectiveness of Leading Inhaled Corticosteroids in Asthma Management

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 815,377 (actual)
• Sponsor: Research in Real-Life Ltd · Network
• Sex: All
• Age: 5 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Extra-fine hydrofluoroalkane-beclomethasone dipropionate	Initiation of HFA-BDP (any dose) in steroid naive patients via MDI
DRUG	Extra-fine hydrofluoroalkane-beclomethasone dipropionate	An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as HFA-BDP via MDI
DRUG	Fluticasone propionate	An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as FP via MDI
DRUG	Beclomethasone dipropionate	An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as CFC-BDP via MDI
DRUG	fluticasone propionate	Initiation of FP (any dose) via MDI in steroid naive patient
DRUG	Chlorofluorocarbon beclomethasone dipropionate	Initiation of CFC-BDP (any dose) via MDI in steroid naive patient

Timeline

• Start date: 2001-01-01
• Primary completion: 2007-06-01
• Completion: 2010-07-01
• First posted: 2010-06-10
• Last updated: 2013-03-14

Locations

1 site across 1 country: United Kingdom