Real Life Effectiveness of Easyhaler (Orion)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24003 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Initiation cohort

Receive their first prescription for ICS therapy as one of the study drugs

Budesonide Easyhaler

Intervention Type DEVICE

Budesonide dry powder inhaler

Intervention Type DEVICE

Step-up cohort

Receive a prescription for one of the study drugs at a dose ≥50% that of their prescribed ICS dose during baseline.

Budesonide Easyhaler

Intervention Type DEVICE

Budesonide dry powder inhaler

Intervention Type DEVICE

Switch cohort

switch from BUD DPI (other) to BUD EH or continue on BUD DPI (other) with no change in ICS dose

Budesonide Easyhaler

Intervention Type DEVICE

Budesonide dry powder inhaler

Intervention Type DEVICE

Interventions

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Budesonide Easyhaler

Intervention Type DEVICE

Budesonide dry powder inhaler

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No