Effectiveness and Cost-effectiveness Evaluation of Easyhaler Versus Other Devices in a Real World Primary Care Population
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All trials for Asthma All trials of Budesonide Easyhaler All trials of Budesonide dry powder inhaler
-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.
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+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).
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Initiation cohort | | Device: Budesonide Easyhaler; Device: Budesonide dry powder inhaler | Receive their first prescription for ICS therapy as one of the study drugs |
| Step-up cohort | | Device: Budesonide Easyhaler; Device: Budesonide dry powder inhaler | Receive a prescription for one of the study drugs at a dose ≥50% that of their prescribed ICS dose during baseline. |
| Switch cohort | | Device: Budesonide Easyhaler; Device: Budesonide dry powder inhaler | switch from BUD DPI (other) to BUD EH or continue on BUD DPI (other) with no change in ICS dose |
- Budesonide Easyhaler (Device)
- Budesonide dry powder inhaler (Device)
+Outcome measures
Primary outcomes
- asthma control (excluding SABA usage) [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.
- exacerbations (ATS definition) [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.
- exacerbations (Clinical definition) [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.
- asthma control (including SABA usage) [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.
Secondary outcomes
- treatment success definition 1 [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.
- SABA dosages [1 year]: (average daily dose during outcome year)
- adherence to ICS therapy [1 year]: categorised as: <50%, 50-<70%, 70-<100%, ≥100%.
- Medication Possession Ratio (MPR) [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.
- Treatment success (definition 2) [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.
+Eligibility
Sex: All, ages: 6 Years to 80 Years
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.
+Investigators
- David Price, Principal investigator, Research in real life