Real-world Effectiveness and Cost-effectiveness of HFA-beclometasone Compared With ICS/LABA Combination Therapy (QvarvsCombo)

October 3, 2012 updated by: David Price, Research in Real-Life Ltd

A Retrospective Evaluation of Effectiveness and Cost-effectiveness of Extrafine HFA-BDP Compared With Combination ICS/LABA Therapy in the Management of Asthma in a Representative Population of UK Primary Care Patients

This study will compare the effectiveness, cost-effectiveness and direct healthcare costs of asthma management in patients with evidence of persistent asthma following an increase in asthma therapy in the form of either an increased dose of inhaled glucocorticosteroids (ICS) using extrafine hydrofluoroalkane-beclometasone dipropionate (HFA-BDP) via pressurised metered-dose inhaler (pMDI) or breath-actuated inhaler (BAI), or a change to combination ICS plus long-acting bronchodilator (LABA) therapy using fixed combinations (fluticasone propionate / salmeterol [FP/SAL] or budesonide / formoterol [BUD/FOR]) or separate pMDIs and BAIs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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, the patients recruited to asthma RCTs are estimated to represent less than 10% of the United Kingdom's (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.

The fixed combination asthma inhalers, FP/SAL (Seretide) and BUD/FOR (Symbicort) are indicated for use in asthma when adequate asthma control is not achieved with low/medium dose ICS therapy and as-needed (prn) reliever therapy (a short-acting beta-agonist [SABA]). Fixed combination inhalers are also indicated in patients already adequately controlled on separate ICS/LABA therapy. However, emerging trends in asthma prescribing indicate increasing use of add-on therapies (particularly in the form of combination inhalers) in the early stages of asthma therapy, even as first-line therapy.

In practice, there is significant pressure (supported by asthma guidelines) to use the least expensive, effective inhaled therapies available. While the effect of increased use of add-on and combination therapies in terms of patient benefits remains uncertain, the impact on the UK's National Health Service (NHS) treatment costs is unequivocal.

Short, randomised trials of the effectiveness of asthma monotherapies have demonstrated that extrafine HFA-BDP is at least as effective at half the dose as BDP pMDI, and equivalent to same-dose FP pMDI. There is also evidence to suggest that extrafine HFA-BDP optimises deposition in the lung and affords greater tolerance of poor coordination of breathing and inhaler actuation. In addition, one long-term, prospective, randomised, open-labelled trial comparing extrafine HFA-BDP with BDP over the course of one year demonstrated greater improvements in symptom-free days and quality of life in the extrafine HFA-BDP treatment group, at a lower cost per symptom-free day.

The hypothesis for this study, therefore, is that extrafine HFA-BDP may be a suitable, and cost-effective, alternative to combination therapy (as fixed or separate inhalers) in children and adults with evidence of persistent asthma.

Study Type

Observational

Enrollment (Actual)

815377

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • General Practice Research Database

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care asthma patients who were receiving ICS therapy (any of BDP, extrafine BDP-HFA, BUD or FP as pMDI or BAI) who, at an index prescription date, underwent either:

(i) an increase in ICS as extrafine HFA-BDP (pMDI or BAI); (ii) a change to combination therapy with a separate LABA pMDI or BAI (no change in drug, device or daily BDP-equivalent dose) (iii) a change to combination therapy via a fixed-combination inhaler (with no increase in daily BDP-equivalent dose).

Description

Inclusion Criteria:

  • Aged: 4-60 years:

    • Paediatric cohort (aged 4-11 years), and
    • Adult cohort (aged 12-60 years)
    • Aged 61-80 years and never smoked for an additional elderly cohort;
  • Evidence of asthma: i.e. a diagnostic code of asthma or at least 2 asthma prescriptions, including one ICS prescription, at different points in time during the year prior to IPD (the baseline year)
  • Be on current asthma therapy: i.e. at least 1 asthma prescription in the year prior to IPD, and at least 1 other asthma prescription during the same period
  • Have at least one year of up-to-standard (UTS) baseline data (prior to the IPD) and at least one year of UTS outcome data (following the 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 (other than asthma)
  • any patients receiving a combination inhaler in addition to their separate ICS inhaler in the baseline year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Step-up as FDC ICS/LABA
ICS asthma patients who increased therapy as FDC ICS/LABA (no increase in daily ICS dose).
Step up as separate therapies
ICS asthma patients who increased therapy as ICS / LABA via separate pMDI and / or BAI inhalers (no increase in daily ICS dose).
Drug: ICS / LABA via separate pMDI and / or BAI inhalers
A step-up from baseline ICS therapy via the addition of a separate long-acting beta-agonist with no change in baseline ICS drug or dose
Other Names:
  • ICS+LABA separates
Qvar step-up
ICS asthma patients who increased therpy as extra-fine hydrofluoroalkane-beclometasone dipropionate
Drug: Extra-fine hydrofluoroalkane-beclometasone dipropionate
Increase in the baseline BDP-equivalent dose of inhaled corticosteroid as HFA-BDP via pMDI or BAI
Other Names:
  • Qvar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proxy asthma control
Time Frame: One-year outcome period
  • No recorded hospital attendance for asthma including admission, Accident & Emergency (A&E) attendance, out of hours attendance or Out-Patient Department (OPD) attendance, AND
  • No prescriptions for oral steroid, AND
  • No consultations, hospital admissions or A&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics
One-year outcome period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of therapeutic regimen
Time Frame: One-year outcome period

Defined as the absence of (i) Exacerbation:

  1. Unscheduled hospital admissions / A&E attendance for asthma, OR
  2. Acute use of oral steroids

AND

(ii) No consultations, hospital admissions or A&E attendance for LRTI requiring antibiotics

AND

(iii) No change in therapeutic regimen:

  1. Increased dose of ICS, and/or
  2. Change in ICS/LABA, and/or
  3. Change in delivery device, and/or
  4. Use of additional therapy as defined by: theophylline, LTRAs, oral beta agonists (or LABAs in patients receiving extrafine HFA-BDP).
One-year outcome period
Success of therapeutic regimen (sensitivity - independent of cost saving)
Time Frame: One-year outcome period

Success: defined as the absence of

(i) Exacerbation:

  1. Unscheduled hospital admissions / A&E attendance for asthma, OR
  2. Acute use of oral steroids

AND

(ii) No consultations, hospital admissions or A&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics

AND

(iii) No change in therapeutic regimen:

  1. Increased dose of ICS, and/or
  2. Use of additional therapy as defined by: theophylline, leukotreine receptor antagonists (LTRAs), oral beta agonists (or LABAs in patients receiving extrafine HFA-BDP).
One-year outcome period
average SABA daily dose during outcome year
Time Frame: One-year outcome period
Average daily dose categorised as: 0mcg, >0-100mcg, >100-200mcg, >200-400mcg, >400-800mcg, >800mcg).
One-year outcome period
Hospitalisations
Time Frame: One-year outcome period
Mean number of asthma and respiratory-related hospitalisations recorded per patient during the outcome year
One-year outcome period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research in Real-Life Ltd

Collaborators

Teva Branded Pharmaceutical Products R&D, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1991

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

September 28, 2012

First Submitted That Met QC Criteria

October 1, 2012

First Posted (Estimate)

October 2, 2012

Study Record Updates

Last Update Posted (Estimate)

October 4, 2012

Last Update Submitted That Met QC Criteria

October 3, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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