Real Life Effectiveness of Easyhaler (Orion)

Completed

• Conditions: Asthma
• Interventions: Device: Budesonide Easyhaler; Device: Budesonide dry powder inhaler

• 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

Arm && Interventions

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

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.