Real Life Effectiveness of Easyhaler (Orion)

Completed

• Conditions: Asthma

• Registration Number: NCT02048930
• Lead Sponsor: Research in Real-Life Ltd

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).

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-01
• Study First Submitted: 2014-01-27
• Study First Submitted QC: 2014-01-28
• Last Update Submitted: 2014-01-28
• Study First Posted: 2014-01-29
• Last Update Posted: 2014-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24003

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.