Real Life Effectiveness of Easyhaler (Orion)

January 28, 2014 updated by: Research in Real-Life Ltd

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

24003

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

6 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

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:

    1. Initiation - a diagnostic code for asthma
    2. 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.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Initiation cohort
Receive their first prescription for ICS therapy as one of the study drugs
Device: Budesonide Easyhaler
Device: Budesonide dry powder inhaler
Step-up cohort
Receive a prescription for one of the study drugs at a dose ≥50% that of their prescribed ICS dose during baseline.
Device: Budesonide Easyhaler
Device: Budesonide dry powder inhaler
Switch cohort
switch from BUD DPI (other) to BUD EH or continue on BUD DPI (other) with no change in ICS dose
Device: Budesonide Easyhaler
Device: Budesonide dry powder inhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 :

  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.
1 year
exacerbations (ATS definition)
Time Frame: 1 year

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.
1 year
exacerbations (Clinical definition)
Time Frame: 1 year

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.
1 year
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 :

  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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

  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:

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

Unsuccessful: all others.
1 year
SABA dosages
Time Frame: 1 year
(average daily dose during outcome year)
1 year
adherence to ICS therapy
Time Frame: 1 year
categorised as: <50%, 50-<70%, 70-<100%, ≥100%.
1 year
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.
1 year
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:

  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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research in Real-Life Ltd

Collaborators

Orion Corporation, Orion Pharma

Investigators

  • Principal Investigator: David Price, Research in Real Life

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

September 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

January 27, 2014

First Submitted That Met QC Criteria

January 28, 2014

First Posted (Estimate)

January 29, 2014

Study Record Updates

Last Update Posted (Estimate)

January 29, 2014

Last Update Submitted That Met QC Criteria

January 28, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R02411

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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