Asthma
Conditions
Keywords
GPRD, effectiveness, cost-effectiveness, Easyhaler, Primary care, DPI
Brief 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.
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).
Interventions
DEVICEBudesonide Easyhaler
Sponsors
Orion Corporation, Orion Pharma
Research in Real-Life Ltd
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Outcome results
None listed