Real-life Effectiveness and Cost-effectiveness of Qvar Versus FP and BDP in the Management of COPD (QvarCOPD)

Research in Real-Life

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Fluticasone propionate metred dose inhaler; Drug: Extra-fine hydrofluoroalkane beclomethasone MDI; Drug: Chlorofluorocarbon beclomethasone dipropionate; Drug: Chlorofluorocarbon beclomethasone metered dose inhaler; Drug: Hydrofluoroalkane beclomethasone metred dose inhaler

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT01141452

BA5

Details and patient eligibility

About

The objective of this study is to compare the effectiveness, cost-effectiveness and direct healthcare costs of managing chronic obstructive pulmonary disease (COPD) in primary care patients with evidence of COPD who either initiate inhaled corticosteroid (ICS) therapy, or have an increase in their ICS dose, as hydrofluoroalkane (HFA) beclometasone dipropionate (BDP) (hereafter Qvar®), CFC-BDP (hereafter BDP) and fluticasone propionate (FP) via pressurised metered-dose inhalers.

Full description

Current asthma guidelines in the UK are underpinned by evidence derived from randomised controlled trials (RCTs). Although RCT data are considered the gold standard, patients recruited to asthma RCTs are estimated to represent less than 10% of the UK's asthma population. 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 observational studies to inform existing guidelines and help optimise asthma outcomes.

Short randomised trials have shown that Qvar is at least as effective as FP pMDI and as BDP pMDI at half the prescribed dose in patients with asthma. There is also evidence to suggest that, in adults, HFA formulation as used by Qvar (featuring BDP in solution rather than suspension) may achieve 10-fold higher deposition compared with CFC-BDP.4 Furthermore, deposition in the peripheral regions is higher compared with CFC-BDP and the fine-particle formulation also offers greater tolerance of poor co-ordination of breathing and inhaler actuation, resulting in lower oro-pharyngeal deposition compared with CFC-BDP.

Evidence of the efficacy of ICS monotherapy in COPD remains mixed at this time. While Qvar and ICS monotherapy use in the treatment of COPD is currently off-label, it occurs in clinical practice in two common scenarios:

1. before a diagnosis of COPD is made
2. unlicensed use as monotherapy, or in combination with long-acting bronchodilators

The study hypothesis, therefore, is that Qvar treatment in COPD may be associated with improved disease management and control (as assessed by effectiveness, cost-effectiveness and direct healthcare costs of managing COPD) compared with other commonly used ICS therapies, namely BPD and FP, by virtue of its improved deposition throughout the lungs and the small airways.

Enrollment: 815,377 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged ≥40 years at index prescription date

• COPD diagnosis:

  • diagnostic code, and

  • ≥2 prescriptions for COPD therapy in baseline year (at different points in time)

    • For the ICS increase cohort (i.e. IPDA) ≥1 of these prescriptions must be for ICS therapy.
    • Commence ICS therapy at any time (even if before COPD diagnosis is made)

Exclusion criteria

• A diagnostic read code for any other chronic respiratory disease (except asthma)

Trial design

815,377 participants in 6 patient groups

IPDA FP MDI

Description:

Patients who were on inhaled corticosteroid therapy as part of their baseline therapy (any ICS therapy) who, at an index prescription date, stepped-up ICS dose as fluticasone via metered dose inhaler

Treatment:

Drug: Fluticasone propionate metred dose inhaler

Drug: Fluticasone propionate metred dose inhaler

IPDA HFA-BDP MDI

Description:

Patients who were on inhaled corticosteroid therapy as part of their baseline therapy (any ICS therapy) who, at an index prescription date, stepped-up ICS dose as extra-fine hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler

Treatment:

Drug: Extra-fine hydrofluoroalkane beclomethasone MDI

IPDA CFC-BDP MDI

Description:

Patients who were on inhaled corticosteroid therapy as part of their baseline therapy (any ICS therapy) who, at an index prescription date, stepped-up ICS dose as chlorofluorocarbon beclomethasone dipropionate via metered dose inhaler

Treatment:

Drug: Chlorofluorocarbon beclomethasone metered dose inhaler

IPDI CFC-BDP MDI

Description:

Patients who were not receiving inhaled corticosteroid therapy as part of their baseline therapy but who, at an index prescription date, initiated ICS as chlorofluorocarbon beclomethasone dipropionate via metered dose inhaler

Treatment:

Drug: Chlorofluorocarbon beclomethasone dipropionate

IPDI HFA-BDP MDI

Description:

Patients who were not receiving inhaled corticosteroid therapy as part of their baseline therapy but who, at an index prescription date, initiated ICS as hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler

Treatment:

Drug: Hydrofluoroalkane beclomethasone metred dose inhaler

IPDI FP MDI

Description:

Patients who were not receiving inhaled corticosteroid therapy as part of their baseline therapy but who, at an index prescription date, initiated ICS as fluticasone propionate via metered dose inhaler

Treatment:

Drug: Fluticasone propionate metred dose inhaler

Drug: Fluticasone propionate metred dose inhaler