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

This study has been completed.
Sponsor:
Collaborator:
Teva Pharmaceutical Industries
Information provided by:
Research in Real-Life Ltd
ClinicalTrials.gov Identifier:
NCT01313585
First received: March 10, 2011
Last updated: March 11, 2011
Last verified: March 2011
  Purpose

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).


Condition Intervention
Asthma
Drug: Initiation of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe device
Drug: Initiation of beclometasone via the Easibreathe device plus salbutamol via and MDI device
Drug: Increase of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe device
Drug: Increase of beclometasone via the Easibreathe device plus salbutamol via an MDI

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Proxy asthma control [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]

    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.

  • Total number of asthma exacerbations and exacerbation rate ratio [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]

    Where exacerbation is defined as an occurrence of:

    • Unscheduled hospital admissions / A&E attendance for asthma, OR
    • Use of oral steroids


Secondary Outcome Measures:
  • Treatment success 1 [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]

    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).

  • Treatment success 2 (independent of possible cost savings) [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]

    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).

  • Respiratory-related hospitalisations and referrals. [ Time Frame: One-year outcome period ] [ Designated as safety issue: Yes ]
    Mean number of respiratory-related hospitalisations and referrals per patient recorded during the one-year outcome period


Enrollment: 815377
Study Start Date: January 1991
Study Completion Date: March 2010
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   4 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
Criteria

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).
  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: NCT01313585

Locations
United Kingdom
General Practice Research Database
London, United Kingdom
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
ClinicalTrials.gov Identifier: NCT01313585     History of Changes
Other Study ID Numbers: 003/10
Study First Received: March 10, 2011
Last Updated: March 11, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Research in Real-Life Ltd:
Primary care
asthma management
inhaler device
maintenance therapy
reliever therapy
Easibreathe salbutamol

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Albuterol
Beclomethasone
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014