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Completed

NCT Number: NCT01141439

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

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).

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Key information

Age range

5 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

General Practice Research Database

London, SW8 5NQ, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Extra-fine hydrofluoroalkane-beclomethasone dipropionate

Drug

Initiation of HFA-BDP (any dose) in steroid naive patients via MDI

Other names: Qvar®

Fluticasone propionate

Drug

An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as FP via MDI

Beclomethasone dipropionate

Drug

An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as CFC-BDP via MDI

Chlorofluorocarbon beclomethasone dipropionate

Drug

Initiation of CFC-BDP (any dose) via MDI in steroid naive patient

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.
  2. 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
  3. 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.
  4. 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)
  5. Use of anti-fungals

    Time frame: One-year

    defined as incidences of definite oral candidiasis

  6. 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.

Sponsors and collaborators

Lead sponsor

Research in Real-Life Ltd

Network

Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

Registry information

Official study title

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

Acronym: QvarAsthma

Important dates

Study start
2001
Primary completion
2007
Study completion
2010
First posted
Jun 10, 2010
Registry last updated
Mar 14, 2013

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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