Real Life Effectiveness of Easyhaler (Orion)

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Asthma

Intervention / Treatment
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* Device: Budesonide Easyhaler
* Device: Budesonide dry powder inhaler


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 : 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. | 1 year | 
| exacerbations (ATS definition) | 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. | 1 year | 
| exacerbations (Clinical definition) | 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. | 1 year | 
| 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 : 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. | 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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effectiveness, cost-effectiveness, Easyhaler, Primary care, DPI, GPRD