Device Mixing in Asthma, a General Practice Research Database Study (EBsalbutamol)

March 11, 2011 updated by: Research in Real-Life Ltd

Retrospective, Real-life Observational Evaluation of the Effectiveness of Mixed Maintenance and Reliever Inhaler Types in Patients in the Management of Asthma in a Representative UK Primary Care Population

This study will compare the absolute and relative effectiveness of asthma management in patients on inhaled corticosteroid (ICS) maintenance therapy as Easi-breathe® (EB) - beclometasone dipropionate (BDP) breath-actuated inhaler (BAI) - and as-needed (prn) reliever medication (short-acting beta2-agonist [SABA] therapy) via either a BAI (i.e. Easi-breathe® [EB] salbutamol) or via a pressurised metered dose inhaler (MDI) (e.g. MDI salbutamol).

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, 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.

Inhalation therapy is the cornerstone of asthma treatment, used for the delivery of 'reliever' bronchodilator therapy (e.g. salbutamol) as well as anti-inflammatory corticosteroid 'maintenance' or 'controller' therapy. Currently available inhaler devices include MDIs, breath-actuated MDIs (BAIs), and dry powder inhalers (DPIs). Both BAIs and DPIs are actuated by the patient's inhalation manoeuvre, while MDIs are actuated by the patient's pressing of a button, which must thus be coordinated with inhalation. The clinical effectiveness of inhalation therapy derives from delivery of drug to the target sites in the lungs, and evidence is mounting that suboptimal use of inhaler devices is a common problem contributing to compromised asthma control for many patients. Indeed, decreased asthma control has been linked to the number of mistakes when using MDIs for delivering inhaled corticosteroids (ICS).

There is also evidence that the ability of patients to use the different inhaler device types is variable. Nonetheless, recent reviews of RCTs, while recognising the importance of inhaler technique, have concluded that inhaler devices do not differ significantly in efficacy and that the cheapest inhaler device should be used. However, as results are based on RCTs they should be applied with care in light of the aforementioned issues around external validity of RCTs and the ability to extrapolate their findings across a broad patient population. Moreover, patients enrolled in RCTs typically receive extensive training and must demonstrate and maintain proper inhaler technique, seldom accomplished in a real-world setting.

The aim of this study is to compare the absolute and relative effectiveness of ICS (maintenance) plus SABA (reliever) therapy delivered via same-type devices (namely BDP via EB plus salbutamol via EB [BAI]) and that delivered via different device types (i.e. BDP via EB [BAI] plus SABA via MDI) in a real-life, representative, UK primary care asthma population.

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

4 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Asthma patients on SABA therapy (any available) monotherapy who, at the index date, either:

(i) IPDI: initiate ICS therapy as BDP EB at the index date and also receive reliever therapy as either*:

  • Salbutamol EB, or
  • Salbutamol MDI, OR, who (ii) IPDA: receive a recorded increase in ICS therapy as BDP EB at the index date and also receive reliever therapy as either*:
  • Salbutamol EB, or
  • Salbutamol MDI.

Description

Inclusion Criteria:

  • Aged: 4-80 years:

    • Paediatric cohort (aged 4-11 years), and
    • Adult cohort (aged 12-80 years )

  • Evidence of asthma:

    • a diagnostic code for asthma, and / or
    • ≥2 prescriptions for asthma at different points in time during the prior year and/ or
    • ≥2 prescriptions for asthma therapies during the outcome year, including ≥1 ICS prescription (in addition to that received at IPD) - IPDI cohort only

  • Be on current asthma therapy (for the IPDA cohort only):

    • ≥1 ICS prescription in the prior year, and
    • ≥1 other asthma prescription during the baseline year.
  • 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 COPD read code at any time; and/or
  • received a combination inhaler in addition to a separate ICS inhaler in the baseline year; and/or
  • received a long-acting beta2-agonsist (LABA) in addition to a separate ICS inhaler in the baseline year
  • received ICS therapy during baseline year via DPI (in IPDA cohort only).

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IPDA salbutamol MDI
receive a recorded increase in ICS therapy as BDP Easibreathe at the index date and also receive salbutamol MDI
Drug: Increase of beclometasone via the Easibreathe device plus salbutamol via an MDI
IPDA salbutamol EB
receive a recorded increase in ICS therapy as BDP Easibreathe at the index date and also receive salbutamol Easibreathe
Drug: Increase of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe device
IPDI salbutamol EB
initiate ICS therapy as BDP Easibreathe at the index date and also receive salbutamol Easibreathe
Drug: Initiation of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe device
IPDI salbutamol MDI
initiate ICS therapy as BDP Easibreathe at the index date and also receive salbutamol MDI
Drug: Initiation of beclometasone via the Easibreathe device plus salbutamol via and MDI device

What is the study measuring?

Primary Outcome Measures

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

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 steroids, AND
  • No GP consultations, hospital admissions or A&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics.
One-year outcome period
Total number of asthma exacerbations and exacerbation rate ratio
Time Frame: One-year outcome period

Where exacerbation is defined as an occurrence of:

  • Unscheduled hospital admissions / A&E attendance for asthma, OR
  • Use of oral steroids
One-year outcome period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment success 1
Time Frame: One-year outcome period

Success: defined as:

(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. Change in ICS/LABA, and/or
  3. Change in delivery device, and/or
  4. Use of additional therapy as defined by: theophylline, leukotreine receptor antagonists (LTRAs).
One-year outcome period
Treatment success 2 (independent of possible cost savings)
Time Frame: One-year outcome period

Success: defined as:

(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).
One-year outcome period
Respiratory-related hospitalisations and referrals.
Time Frame: One-year outcome period
Mean number of respiratory-related hospitalisations and referrals per patient recorded during the one-year outcome period
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)

March 1, 2010

Study Registration Dates

First Submitted

March 10, 2011

First Submitted That Met QC Criteria

March 11, 2011

First Posted (ESTIMATE)

March 14, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 14, 2011

Last Update Submitted That Met QC Criteria

March 11, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 003/10

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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