Real Life Effectiveness of Easyhaler (Orion)

Research in Real-Life

Status: Completed

Conditions: Asthma

Treatments: Device: Budesonide Easyhaler; Device: Budesonide dry powder inhaler

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT02048930

R02411

Details and patient eligibility

About

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.

Full 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).

Enrollment: 24,003 patients

Sex: All

Ages: 6 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

24,003 participants in 3 patient groups

Initiation cohort

Description:

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

Treatment:

Device: Budesonide dry powder inhaler

Device: Budesonide Easyhaler

Step-up cohort

Description:

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

Treatment:

Device: Budesonide dry powder inhaler

Device: Budesonide Easyhaler

Switch cohort

Description:

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

Treatment:

Device: Budesonide dry powder inhaler

Device: Budesonide Easyhaler