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Completed

NCT Number: NCT02048930

Real Life Effectiveness of Easyhaler (Orion)

The aim of this study is to compare the clinical effectiveness and cost-effectiveness of the Easyhaler® (EH) device and other DPI devices commonly used in the UK in a UK primary care asthma population of patients aged 6 to 80 years.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

A recent observational study by Price et al carried out using the UK's General Practice Research Database (CPRD) to compare asthma-related outcomes for different inhaled corticosteroid (ICS) inhaler devices, using Easyhaler and dry powder inhalers (DPIs).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients must also meet the following inclusion criteria:
  • (1) Aged: 6-80 years - stratified 6-11 years; 12-60 years; ≥61 years to allow paediatrics and adolescent / adult sub analyses; and to allow for the exclusion of elderly (aged 61+) smokers and ex-smokers if required.
  • (2) On-going asthma therapy: ≥2 prescriptions for asthma during the outcome period (i.e. ≥1 prescription (for any asthma therapy) in addition to the prescription for ICS at IPD (initiation / step-up/ switch).
  • (3) Evidence of active asthma:
  • Initiation - a diagnostic code for asthma
  • Step-up / Switch - ≥2 prescriptions for asthma (at least one of which is for ICS) at different points in time during the baseline year PLUS a diagnostic code for asthma.
  • (4) Have at least one year of up-to-standard (UTS) baseline data and at least one year of UTS outcome data (following the IPD).

Exclusion criteria

  • Patients will be excluded from the analysis if they have:
  • (1) Had a COPD read code at any time; and/or
  • (2) Had any chronic respiratory disease, except asthma, at any time; and/or
  • (3) Patients on maintenance oral steroids during baseline year; and/or
  • (4) Multiple ICS prescriptions at IPD.

Treatment and study plan

Budesonide Easyhaler

Device

Budesonide dry powder inhaler

Device

Primary outcomes

  1. asthma control (excluding SABA usage)

    Time frame: 1 year

    The Composite proxy for asthma control (excluding SABA usage) during the one-year outcome period, which is defined as:

    Controlled: the absence of the following during the one-year outcome period:

    (i) Asthma-related :

    • Hospital attendance or admission
    • A&E attendance, OR
    • Out of hours attendance, OR
    • Out-patient department attendance

    (ii) GP consultations for lower respiratory tract infection

    (iii) Prescriptions for acute courses of oral steroids ;

    Uncontrolled: all others.

  2. exacerbations (ATS definition)

    Time frame: 1 year

    Total number of asthma exacerbations (ATS Definition) defined as an occurrence of:

    (i) Asthma-related:

    • Hospital attendance / admissions OR
    • A&E attendance

    (ii) Use of acute oral steroids.

  3. exacerbations (Clinical definition)

    Time frame: 1 year

    Total number of asthma exacerbations (Clinical Definition) defined as an occurrence of:

    (i) Asthma-related:

    • Hospital attendance / admissions, OR
    • A&E attendance, OR

    (ii) GP consultations for lower respiratory related tract infections

    (iii) Use of acute oral steroids.

  4. asthma control (including SABA usage)

    Time frame: 1 year

    The Composite proxy for asthma control (including SABA usage) during the one-year outcome period, which is defined as:

    Controlled: the absence of the following during the one-year outcome period:

    (iv) Asthma-related :

    • Hospital attendance or admission
    • A&E attendance, OR
    • Out of hours attendance, OR
    • Out-patient department attendance

    (v) GP consultations for lower respiratory tract infection

    (vi) Prescriptions for acute courses of oral steroids ;

    Plus:

    (vii) Average prescribed daily dose ≤200mg of Salbutamol / ≤500mg of terbutaline.

    Uncontrolled: all others.

Secondary outcomes

  1. treatment success definition 1

    Time frame: 1 year

    Treatment Success (Definition 1) defined as:

    Successful: the absence of the following during the one-year outcome period

    (i) Asthma-related:

    • Hospital attendance or admission
    • A&E attendance, OR
    • Out of hours attendance, OR
    • Out-patient department attendance

    (ii) GP consultations for lower respiratory tract infection

    (iii) Prescriptions for acute courses of oral steroids

    (iv) Any additional or change in therapy:

    • Increased dose of ICS (≥50% increase), and/or
    • Change in ICS and/or
    • Change in delivery device, and/or
    • Use of additional therapy as defined by: theophylline and leukotreine receptor antagonists (LTRAs).

    Unsuccessful: all others.

  2. SABA dosages

    Time frame: 1 year

    (average daily dose during outcome year)

  3. adherence to ICS therapy

    Time frame: 1 year

    categorised as: <50%, 50-<70%, 70-<100%, ≥100%.

  4. Medication Possession Ratio (MPR)

    Time frame: 1 year

    The Medication Possession Ratio (MPR) for ICS is defined using the following formula.

    Medication Possession Ratio = (no. of days supply of ICS/365)x 100% The numerator is truncated at 365 if greater than 365. The MPR is a measure of adherence to therapy and a cut-off of 80% has previously been used in categorising asthma patients as adherent or non-adherent; the MPR has therefore been categorised as a dichotomous variable: < 80% and ≥ 80% for this analysis.

  5. Treatment success (definition 2)

    Time frame: 1 year

    Treatment Success (Definition 2) defined as:

    Successful: the absence of the following during the one-year outcome period

    (i) Asthma-related:

    • Hospital attendance or admission
    • A&E attendance, OR
    • Out of hours attendance, OR
    • Out-patient department attendance

    (ii) GP consultations for lower respiratory tract infection

    (iii) Prescriptions for acute courses of oral steroids7

    (iv) Any additional or change in therapy:

    • Increased dose of ICS (≥50% increase), and/or
    • Use of additional therapy as defined by: theophylline and leukotreine receptor antagonists (LTRAs).

    Unsuccessful: all others.

Sponsors and collaborators

Lead sponsor

Research in Real-Life Ltd

Network

Collaborators

  • Orion Corporation, Orion Pharma

Registry information

Official study title

Effectiveness and Cost-effectiveness Evaluation of Easyhaler Versus Other Devices in a Real World Primary Care Population

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 29, 2014
Registry last updated
Jan 29, 2014

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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