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.
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
24,003
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 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 : 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.
Time frame: 1 year
treatment success definition 1
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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.
Time frame: 1 year
SABA dosages
(average daily dose during outcome year)
Time frame: 1 year
adherence to ICS therapy
categorised as: \<50%, 50-\<70%, 70-\<100%, ≥100%.
Time frame: 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.
Time frame: 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: 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.
Time frame: 1 year