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Completed

NCT Number: NCT01141452

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

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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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

General Practice Research Database

London, SW8 5NQ, United Kingdom

About this study

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:

  • before a diagnosis of COPD is made
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Extra-fine hydrofluoroalkane beclomethasone MDI

Drug

Step-up in baseline BDP-equivalent ICS dose

Other names: Qvar®

Chlorofluorocarbon beclomethasone metered dose inhaler

Drug

Step-up in baseline BDP-equivalent ICS dose

Fluticasone propionate metred dose inhaler

Drug

Step-up in baseline BDP-equivalent ICS dose

Hydrofluoroalkane beclomethasone metred dose inhaler

Drug

Initiation of ICS therapy

Other names: Qvar®

Chlorofluorocarbon beclomethasone dipropionate

Drug

Initiation of ICS therapy

Primary outcomes

  1. Total number of exacerbations; exacerbation rate ratio; time to first after IPD

    Time frame: Two-year outcome period

    Where exacerbations are defined as:

    • Unscheduled hospital admissions / A&E attendances:*
    • For COPD (definite code) and
    • Lower respiratory tract infections (LRTI) treated with antibiotics
    • Acute use of oral steroids
    • Antibiotics use with a lower respiratory read code within a ±5-day window

  2. COPD treatment success

    Time frame: Two-year outcome period

    • No recorded hospital attendance for COPD or respiratory related events (i.e. with a lower respiratory read code), including:
    • Admission
    • A&E attendance
    • Out of hours attendance
    • No exacerbations of COPD ("definite" plus "possible" prescriptions as defined above)
    • No consultations, hospital admissions or A&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics.

Secondary outcomes

  1. COPD treatment success factoring in change in therapy

    Time frame: Two-year outcome period

    Defined as absence of:

    • Exacerbations; and/or
    • Increase in dose of inhaled steroid; and/or
    • Change in delivery device, and/or
    • Change in ICS
    • Use of additional therapy not received in baseline year, split by:
    • LABA
    • Theophylline
    • LTRAs.

  2. COPD treatment success factoring in change in therapy unrelated to cost savings

    Time frame: Two-year outcome period

    Defined as absence of:

    • Exacerbations; and/or
    • Increase in dose of inhaled steroid; and/or
    • Use of additional therapy not received in baseline year, split by:
    • LABA
    • Theophylline
    • LTRAs.

  3. Change in ICS dosing

    Time frame: Two-year outcome period

    Proportion of patients who:

    • Remained on the same ICS (and/or combination therapy) throughout the outcome period
    • Remained on the same ICS dose throughout the outcome period, but had another therapy added
    • Received an ICS dose increase and / or therapy added to their ICS during the outcome period.

  4. Rate of hospitalisations

    Time frame: Two-year outcomes

    Where hospitalisations are defined as

    • Admissions and A&E coded as:
    • lower respiratory-related, or
    • for COPD
    • Admissions and A&E coded as:
    • lower respiratory-related, or
    • for COPD
    • admission attendance occurring within a ±7 day window of an LRTI treated with antibiotics.

  5. SABA usage

    Time frame: Two-year outcome

    Average SABA daily dose, categorised as: 0mcg, >0-100mcg, >100-200mcg, >200-400mcg, >400-800mcg, >800mcg.

  6. Mortality

    Time frame: Two-years

    • Respiratory mortality
    • All-cause mortality

  7. Incidence of pneumonia

    Time frame: Two-year outcome

    • Unconfirmed (i.e. all unique patients with codes for pneumonia) AND
    • Confirmed:
    • chest X-ray within a month of a pneumonia diagnosis, or
    • hospitalisation within a month of a pneumonia diagnosis

  8. Incremental cost effectiveness ratio

    Time frame: Two-year outcome

    Difference in costs (HFA-BDP the comparator) over difference in effectiveness (using primary outcome of exacerbations)

  9. Cost of total healthcare treatment

    Time frame: Two-year outcome

    Costs for each intervention:

    • including ICS costs
    • excluding ICS costs

  10. Costs for COPD treatment

    Time frame: Two-year outcome

    Costs of COPD treatment:

    • including ICS costs
    • excluding ICS costs

Sponsors and collaborators

Lead sponsor

Research in Real-Life Ltd

Network

Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

Registry information

Official study title

Retrospective, Real-life Evaluation of the Effectiveness, Cost-effectiveness and Direct Healthcare Costs of Qvar Pressurised Metered-dose Inhaler (pMDI) Compared With Beclometasone Dipropionate pMDI and Fluticasone pMDI in the Management of Chronic Obstructive Pulmonary Disease (COPD) in a Representative UK Primary Care Patient Population

Acronym: QvarCOPD

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Jun 10, 2010
Registry last updated
Mar 8, 2011

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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