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

Research in Real-Life

Status: Completed

Conditions: Asthma

Treatments: Drug: Fluticasone propionate; Drug: Extra-fine hydrofluoroalkane-beclomethasone dipropionate; Drug: Beclomethasone dipropionate; Drug: fluticasone propionate; Drug: Chlorofluorocarbon beclomethasone dipropionate

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT01141439

BA4

Details and patient eligibility

About

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).

Full 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).

Enrollment: 815,377 patients

Sex: All

Ages: 5 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

815,377 participants in 6 patient groups

IPDI HFA-BDP MDI

Description:

Patients who commenced inhaled corticosteroid therapy as HFA-BDP via MDI

Treatment:

Drug: Extra-fine hydrofluoroalkane-beclomethasone dipropionate

Drug: Extra-fine hydrofluoroalkane-beclomethasone dipropionate

IPDI FP MDI

Description:

Patients who commenced inhaled corticosteroid therapy as FP via MDI

Treatment:

Drug: fluticasone propionate

IPDA FP MDI

Description:

Patients who had a step up in inhaled corticosteroid therapy as FP via MDI

Treatment:

Drug: Fluticasone propionate

IPDA HFA-BDP MDI

Description:

Patients who had a step up in inhaled corticosteroid therapy as HFA-BDP via MDI

Treatment:

Drug: Extra-fine hydrofluoroalkane-beclomethasone dipropionate

Drug: Extra-fine hydrofluoroalkane-beclomethasone dipropionate

IPDI CFC-BDP MDI

Description:

Patients who commenced inhaled corticosteroid therapy as CFC-BDP via MDI

Treatment:

Drug: Chlorofluorocarbon beclomethasone dipropionate

IPDA CFC-BDP MDI

Description:

Patients who had a step up in inhaled corticosteroid therapy as CFC-BDP via MDI

Treatment:

Drug: Beclomethasone dipropionate