Real-world Effectiveness and Cost-effectiveness of Leading Inhaled Corticosteroids in Asthma Management (QvarAsthma)

March 13, 2013 updated by: Research in Real-Life Ltd

A Retrospective Evaluation of the Effectiveness and Cost-effectiveness of HFA-BDP MDI (Qvar®) Compared With CFC-BDP MDI and FP MDI Used in the Management of Asthma in a Representative UK UK Primary Care Population

The objective of the study was to compare the effectiveness, cost-effectiveness and direct healthcare costs of managing asthma in patients with evidence of persistent asthma, following the initiation and increased dose of inhaled corticosteroid (ICS) therapy using HFA-BDP (Qvar®) (either as initial therapy or as a step-up therapy) compared with the most commonly prescribed alternative ICS in the UK, CFC-beclometasone (BDP) and fluticasone (FP) as metered dose inhalers (MDIs). Qvar vs FP analyses were split between adults (12-60yrs) and paediatrics (5-11yrs).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

While current UK asthma guidelines are underpinned with evidence from RCTs, much of this evidence has been undertaken in patients who are not representative of the majority of the current UK asthma population. In fact it has been estimated that fewer than 10% of the patients seen in everyday clinical practice would be eligible for inclusion in such trials. 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 and observational studies to inform existing guidelines and help optimise asthma outcomes. A more holistic approach to respiratory research would see RCT evidence complimented by "real-life" data from pragmatic trials and observational studies.

A number of trends are emerged in asthma prescribing that warrant further investigation to ascertain their benefit to both the patient and the NHS. In particular, significant pressure exists to use the cheapest inhaler devices and formulations. An analysis of a pragmatic trial of Qvar versus standard CFC-BDP undertaken by Research in Real Life suggested that Qvar may be offer greater effectiveness in.5,6 In light of these data, the following report details the findings of a study designed to examine the effectiveness of Qvar in real-life clinical practice using the General Practice Research Database (GPRD).

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, SW8 5NQ
        • 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 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care asthma patients receiving who either initiated ICS therapy as any of extrafine HFA-BDP, CFC-BDP of FP via MDI at an index prescription date (IPD), or were on existing ICs therapy (any) and had an increase in ICS dose at IPD as any of extrafine HFA-BDP, CFC-BDP of FP via MDI

Description

Inclusion Criteria:

Included patients must:

  • aged 5-60 years
  • evidence of asthma: a diagnostic code of asthma or ≥2 prescriptions for asthma in baseline year at different points in time including one of ICS
  • on current therapy at the IPD, defined as ≥1 ICS script and ≥1 other asthma prescriptions in the 12 months prior to first change in therapy
  • had definite dosing instructions
  • have at least 1 year of up-to-standard (UTS) baseline data before IPD
  • have at least 1 year of UTS outcome data after 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
  • For the therapy increase patient cohort, any patients receiving a combination inhaler in addition to their separate ICS inhaler in the year prior to IPD were also excluded.

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
IPDI HFA-BDP MDI
Patients who commenced inhaled corticosteroid therapy as HFA-BDP via MDI
Drug: Extra-fine hydrofluoroalkane-beclomethasone dipropionate
Initiation of HFA-BDP (any dose) in steroid naive patients via MDI
Other Names:
  • Qvar®
Drug: Extra-fine hydrofluoroalkane-beclomethasone dipropionate
An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as HFA-BDP via MDI
Other Names:
  • Qvar
IPDI FP MDI
Patients who commenced inhaled corticosteroid therapy as FP via MDI
Drug: fluticasone propionate
Initiation of FP (any dose) via MDI in steroid naive patient
IPDA FP MDI
Patients who had a step up in inhaled corticosteroid therapy as FP via MDI
Drug: Fluticasone propionate
An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as FP via MDI
IPDA HFA-BDP MDI
Patients who had a step up in inhaled corticosteroid therapy as HFA-BDP via MDI
Drug: Extra-fine hydrofluoroalkane-beclomethasone dipropionate
Initiation of HFA-BDP (any dose) in steroid naive patients via MDI
Other Names:
  • Qvar®
Drug: Extra-fine hydrofluoroalkane-beclomethasone dipropionate
An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as HFA-BDP via MDI
Other Names:
  • Qvar
IPDI CFC-BDP MDI
Patients who commenced inhaled corticosteroid therapy as CFC-BDP via MDI
Drug: Chlorofluorocarbon beclomethasone dipropionate
Initiation of CFC-BDP (any dose) via MDI in steroid naive patient
IPDA CFC-BDP MDI
Patients who had a step up in inhaled corticosteroid therapy as CFC-BDP via MDI
Drug: Beclomethasone dipropionate
An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as CFC-BDP via MDI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proxy asthma control
Time Frame: One-year outcome period

Primary composite measure asthma control defined as:

  • 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
Revised asthma control
Time Frame: One-year outcome period

A revised definition of proxy asthma control for sensitivity analysis was defined as:

  • No recorded hospital attendance for asthma including admission, A&E attendance, out of hours attendance or 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
  • Average daily prescribed dose of salbutamol of no more than 200mcg and terbutaline 500mcg.
One-year outcome period
Disaggregated components of the primary control outcome
Time Frame: One-year outcome period
  • Hospital admissions for asthma
  • Consultations and hospital attendances for LRTI requiring antibiotics
  • Prescriptions for oral steroids
  • SABA use
One-year outcome period
Time to the first asthma exacerbation
Time Frame: One-year outcome period

Where an exacerbation is defined as:

  • An occurrence of unscheduled hospital admission/A&E attendances for asthma AND/OR
  • Use of oral steroids.
One-year outcome period
Success of the therapeutic regimen
Time Frame: One-year outcome period

Defined as:

  • Exacerbation AND/OR
  • Increase in dose of ICS AND/OR
  • Change in ICS drug type AND/OR
  • Change in delivery device AND/OR
  • Use of additional therapy as defined by: LABAs, oral steroids, theophylline, leukotriene receptor antagonists (LTRAs)
One-year outcome period
Use of anti-fungals
Time Frame: One-year
defined as incidences of definite oral candidiasis
One-year
Daily dose of ICS (BDP equivalent) at week 52 compared with week 0 and proportion on original dose of BDP Daily dose* of ICS (BDP equivalent) at week 52 compared with week 0 and proportion on original dose of BDP.
Time Frame: One-year outcome period
BDP-equivalent dose were calculated by multiplying the Qvar and FP doses by a factor of 2. The dose at week 52 was compared with that at week 0 in order to identify the proportion of original (week 0) ICS dose.
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, 2001

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

June 9, 2010

First Submitted That Met QC Criteria

June 9, 2010

First Posted (Estimate)

June 10, 2010

Study Record Updates

Last Update Posted (Estimate)

March 14, 2013

Last Update Submitted That Met QC Criteria

March 13, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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