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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

815377 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-01-31

Study Completion Date

2007-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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IPDA FP MDI

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

Fluticasone propionate metred dose inhaler

Intervention Type DRUG

Step-up in baseline BDP-equivalent ICS dose

IPDA HFA-BDP MDI

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

Extra-fine hydrofluoroalkane beclomethasone MDI

Intervention Type DRUG

Step-up in baseline BDP-equivalent ICS dose

IPDA CFC-BDP MDI

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

Chlorofluorocarbon beclomethasone metered dose inhaler

Intervention Type DRUG

Step-up in baseline BDP-equivalent ICS dose

IPDI CFC-BDP MDI

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

Chlorofluorocarbon beclomethasone dipropionate

Intervention Type DRUG

Initiation of ICS therapy

IPDI HFA-BDP MDI

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

Hydrofluoroalkane beclomethasone metred dose inhaler

Intervention Type DRUG

Initiation of ICS therapy

IPDI FP MDI

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

Fluticasone propionate metred dose inhaler

Intervention Type DRUG

Initiation of ICS therapy

Interventions

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Extra-fine hydrofluoroalkane beclomethasone MDI

Step-up in baseline BDP-equivalent ICS dose

Intervention Type DRUG

Chlorofluorocarbon beclomethasone metered dose inhaler

Step-up in baseline BDP-equivalent ICS dose

Intervention Type DRUG

Fluticasone propionate metred dose inhaler

Step-up in baseline BDP-equivalent ICS dose

Intervention Type DRUG

Fluticasone propionate metred dose inhaler

Initiation of ICS therapy

Intervention Type DRUG

Hydrofluoroalkane beclomethasone metred dose inhaler

Initiation of ICS therapy

Intervention Type DRUG

Chlorofluorocarbon beclomethasone dipropionate

Initiation of ICS therapy

Intervention Type DRUG

Other Intervention Names

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Qvar® Qvar®

Eligibility Criteria

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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)