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

This study has been completed.
Sponsor:
Collaborator:
Teva Pharmaceutical Industries
Information provided by:
Research in Real-Life Ltd
ClinicalTrials.gov Identifier:
NCT01141452
First received: June 9, 2010
Last updated: March 7, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Drug: Extra-fine hydrofluoroalkane beclomethasone MDI
Drug: Chlorofluorocarbon beclomethasone metered dose inhaler
Drug: Fluticasone propionate metred dose inhaler
Drug: Hydrofluoroalkane beclomethasone metred dose inhaler
Drug: Chlorofluorocarbon beclomethasone dipropionate

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official 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

Resource links provided by NLM:


Further study details as provided by Research in Real-Life Ltd:

Primary Outcome Measures:
  • Total number of exacerbations; exacerbation rate ratio; time to first after IPD [ Time Frame: Two-year outcome period ] [ Designated as safety issue: No ]

    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

  • COPD treatment success [ Time Frame: Two-year outcome period ] [ Designated as safety issue: No ]
    • 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 Outcome Measures:
  • COPD treatment success factoring in change in therapy [ Time Frame: Two-year outcome period ] [ Designated as safety issue: No ]

    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.

  • COPD treatment success factoring in change in therapy unrelated to cost savings [ Time Frame: Two-year outcome period ] [ Designated as safety issue: No ]

    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.

  • Change in ICS dosing [ Time Frame: Two-year outcome period ] [ Designated as safety issue: No ]

    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.

  • Rate of hospitalisations [ Time Frame: Two-year outcomes ] [ Designated as safety issue: Yes ]

    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.

  • SABA usage [ Time Frame: Two-year outcome ] [ Designated as safety issue: No ]
    Average SABA daily dose, categorised as: 0mcg, >0-100mcg, >100-200mcg, >200-400mcg, >400-800mcg, >800mcg.

  • Mortality [ Time Frame: Two-years ] [ Designated as safety issue: Yes ]
    • Respiratory mortality
    • All-cause mortality

  • Incidence of pneumonia [ Time Frame: Two-year outcome ] [ Designated as safety issue: Yes ]
    • 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

  • Incremental cost effectiveness ratio [ Time Frame: Two-year outcome ] [ Designated as safety issue: No ]
    Difference in costs (HFA-BDP the comparator) over difference in effectiveness (using primary outcome of exacerbations)

  • Cost of total healthcare treatment [ Time Frame: Two-year outcome ] [ Designated as safety issue: No ]

    Costs for each intervention:

    • including ICS costs
    • excluding ICS costs

  • Costs for COPD treatment [ Time Frame: Two-year outcome ] [ Designated as safety issue: No ]

    Costs of COPD treatment:

    • including ICS costs
    • excluding ICS costs


Enrollment: 815377
Study Start Date: January 2001
Study Completion Date: July 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Drug: Fluticasone propionate metred dose inhaler
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
Drug: Extra-fine hydrofluoroalkane beclomethasone MDI
Step-up in baseline BDP-equivalent ICS dose
Other Name: Qvar®
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
Drug: Chlorofluorocarbon beclomethasone metered dose inhaler
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
Drug: Chlorofluorocarbon beclomethasone dipropionate
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
Drug: Hydrofluoroalkane beclomethasone metred dose inhaler
Initiation of ICS therapy
Other Name: Qvar®
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
Drug: Fluticasone propionate metred dose inhaler
Initiation of ICS therapy

Detailed 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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care COPD patients who at an index prescription date either initiated ICS therapy as extrafine HFA-BDP, CFC-BDP or FP via MDI or had an increase in baseline BDP-equivalent ICS dose the index data as extrafine HFA-BDP, CFC-BDP or FP via MDI

Criteria

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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141452

Locations
United Kingdom
General Practice Research Database
London, United Kingdom, SW8 5NQ
Sponsors and Collaborators
Research in Real-Life Ltd
Teva Pharmaceutical Industries
Investigators
Principal Investigator: David Price, Prof. MD Company Director
Study Director: Alison Chisholm, MSc Research Project Director
  More Information

Additional Information:
Publications:
Responsible Party: Professor David Price, Research in Real Life Limited
ClinicalTrials.gov Identifier: NCT01141452     History of Changes
Other Study ID Numbers: BA5
Study First Received: June 9, 2010
Last Updated: March 7, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Research in Real-Life Ltd:
chronic obstructive pulmonary disease
inhaled corticosteroid
increase
initiate
exacerbations
treatment success

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Beclomethasone
Fluticasone
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014