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AsthmaNCT02048930

Real Life Effectiveness of Easyhaler (Orion)

An observational study of Asthma, run by Research in Real-Life Ltd.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 6 to 80 years
Conditions the study is for
Asthma
What is being tested?
Budesonide Easyhaler and Budesonide dry powder inhaler
Type of treatment
Medical device
How many people
24,003 participants
Where
No sites listed yet
Study dates
Sep 2012to Mar 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: This will be a retrospective, observational study consisting of a one-year baseline period immediately prior to an index prescription date (IPD), and a one-year outcome period immediately following the index date. At the IPD, patients either: * Initiation cohort: receive their first prescription for ICS therapy as one of the study drugs * Step-up cohort: receive a prescription for one of the study drugs at a dose ≥50% that of their prescribed ICS dose during baseline. * Switch cohort: switch from BUD DPI (other) to BUD EH or continue on BUD DPI (other) with no change in ICS dose

Who may be able to join

  • 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).

Who cannot join

  • 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.

About this study

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

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.

Read the detailed description

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).

Conditions
Asthma
Being tested
Budesonide Easyhaler, Budesonide dry powder inhaler
Keywords
GPRD, effectiveness, cost-effectiveness, Easyhaler, Primary care, DPI
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Budesonide EasyhalerDevice

  • Budesonide dry powder inhalerDevice

Study groups in NCT02048930
Study groupRoleWhat they receive
Initiation cohortReceive their first prescription for ICS therapy as one of the study drugs
Receives: Device: Budesonide Easyhaler; Device: Budesonide dry powder inhaler
Step-up cohortReceive a prescription for one of the study drugs at a dose ≥50% that of their prescribed ICS dose during baseline.
Receives: Device: Budesonide Easyhaler; Device: Budesonide dry powder inhaler
Switch cohortswitch from BUD DPI (other) to BUD EH or continue on BUD DPI (other) with no change in ICS dose
Receives: Device: Budesonide Easyhaler; Device: Budesonide dry powder inhaler

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. asthma control (excluding SABA usage)

    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 :

    1. Hospital attendance or admission
    2. A\&E attendance, OR
    3. Out of hours attendance, OR
    4. Out-patient department attendance (ii) GP consultations for lower respiratory tract infection (iii) Prescriptions for acute courses of oral steroids ;

    Uncontrolled: all others.

    Measured: 1 year

  2. exacerbations (ATS definition)

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

    (i) Asthma-related:

    1. Hospital attendance / admissions OR
    2. A\&E attendance (ii) Use of acute oral steroids.

    Measured: 1 year

  3. exacerbations (Clinical definition)

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

    (i) Asthma-related:

    1. Hospital attendance / admissions, OR
    2. A\&E attendance, OR (ii) GP consultations for lower respiratory related tract infections (iii) Use of acute oral steroids.

    Measured: 1 year

  4. asthma control (including SABA usage)

    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 :

    1. Hospital attendance or admission
    2. A\&E attendance, OR
    3. Out of hours attendance, OR
    4. 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.

    Measured: 1 year

Secondary outcomes (5)

  1. treatment success definition 1

    Treatment Success (Definition 1) defined as:

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

    (i) Asthma-related:

    1. Hospital attendance or admission
    2. A\&E attendance, OR
    3. Out of hours attendance, OR
    4. 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:
    5. Increased dose of ICS (≥50% increase), and/or
    6. Change in ICS and/or
    7. Change in delivery device, and/or
    8. Use of additional therapy as defined by: theophylline and leukotreine receptor antagonists (LTRAs).

    Unsuccessful: all others.

    Measured: 1 year

  2. SABA dosages

    (average daily dose during outcome year)

    Measured: 1 year

  3. adherence to ICS therapy

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

    Measured: 1 year

  4. Medication Possession Ratio (MPR)

    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.

    Measured: 1 year

  5. Treatment success (definition 2)

    Treatment Success (Definition 2) defined as:

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

    (i) Asthma-related:

    1. Hospital attendance or admission
    2. A\&E attendance, OR
    3. Out of hours attendance, OR
    4. 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:
    5. Increased dose of ICS (≥50% increase), and/or
    6. Use of additional therapy as defined by: theophylline and leukotreine receptor antagonists (LTRAs).

    Unsuccessful: all others.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2014 (estimated)
  2. Study startSep 2012
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
24,003 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02048930
Sponsor's protocol ID
R02411
Status last verified
Jan 2014
First submitted
27 Jan 2014
Last updated
29 Jan 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by Research in Real-Life Ltd.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

asthma control (excluding SABA usage) (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02048930.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2014.

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