Real Life Effectiveness of Easyhaler (Orion)

Asthma Clinical Trial

Official title:

Effectiveness and Cost-effectiveness Evaluation of Easyhaler Versus Other Devices in a Real World Primary Care Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02048930
• Other study ID #: R02411
• Status: Completed
• Phase: N/A
• First received: January 27, 2014
• Last updated: January 28, 2014
• Start date: September 2012
• Est. completion date: March 2013

Study information

• Verified date: January 2014
• Source: Research in Real-Life Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24003
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Budesonide Easyhaler

• Budesonide dry powder inhaler

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Research in Real-Life Ltd	Orion Corporation, Orion Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 : Hospital attendance or admission; A&E attendance, OR; Out of hours attendance, OR; Out-patient department attendance; (ii) GP consultations for lower respiratory tract infection; (iii) Prescriptions for acute courses of oral steroids ; Uncontrolled: all others.	1 year	No
Primary	exacerbations (ATS definition)	Total number of asthma exacerbations (ATS Definition) defined as an occurrence of: (i) Asthma-related: Hospital attendance / admissions OR; A&E attendance; (ii) Use of acute oral steroids.	1 year	No
Primary	exacerbations (Clinical definition)	Total number of asthma exacerbations (Clinical Definition) defined as an occurrence of: (i) Asthma-related: Hospital attendance / admissions, OR; A&E attendance, OR; (ii) GP consultations for lower respiratory related tract infections; (iii) Use of acute oral steroids.	1 year	No
Primary	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 : Hospital attendance or admission; A&E attendance, OR; Out of hours attendance, OR; 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.	1 year	No
Secondary	treatment success definition 1	Treatment Success (Definition 1) defined as: Successful: the absence of the following during the one-year outcome period; (i) Asthma-related: Hospital attendance or admission; A&E attendance, OR; Out of hours attendance, OR; 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: Increased dose of ICS (=50% increase), and/or; Change in ICS and/or; Change in delivery device, and/or; Use of additional therapy as defined by: theophylline and leukotreine receptor antagonists (LTRAs).; Unsuccessful: all others.	1 year	No
Secondary	SABA dosages	(average daily dose during outcome year)	1 year	No
Secondary	adherence to ICS therapy	categorised as: <50%, 50-<70%, 70-<100%, =100%.	1 year	No
Secondary	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.	1 year	No
Secondary	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: Hospital attendance or admission; A&E attendance, OR; Out of hours attendance, OR; 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: Increased dose of ICS (=50% increase), and/or; Use of additional therapy as defined by: theophylline and leukotreine receptor antagonists (LTRAs).; Unsuccessful: all others.	1 year	No

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