Clinical trial NCT02048930: Real Life Effectiveness of Easyhaler (Orion)
Official title: Effectiveness and Cost-effectiveness Evaluation of Easyhaler Versus Other Devices in a Real World Primary Care Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: GPRD
effectiveness
cost-effectiveness
Easyhaler
Primary care
DPI
Lead sponsor: Research in Real-Life Ltd
Sponsor class: NETWORK
Collaborators: name: Orion Corporation, Orion Pharma
First posted: 2014-01-29
Enrollment: 24003
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This will be a retrospective, observational study consisting of a one-year baseline period immediately prior to an index prescription date (IPD), and a one-year outcome period immediately following the index date.

At the IPD, patients either:

* Initiation cohort: receive their first prescription for ICS therapy as one of the study drugs
* Step-up cohort: receive a prescription for one of the study drugs at a dose ≥50% that of their prescribed ICS dose during baseline.
* Switch cohort: switch from BUD DPI (other) to BUD EH or continue on BUD DPI (other) with no change in ICS dose

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).

Eligibility criteria: 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.

Primary outcomes:
measure: asthma control (excluding SABA usage)
timeFrame: 1 year
measure: exacerbations (ATS definition)
timeFrame: 1 year
measure: exacerbations (Clinical definition)
timeFrame: 1 year
measure: asthma control (including SABA usage)
timeFrame: 1 year
Secondary outcomes:
measure: treatment success definition 1
timeFrame: 1 year
measure: SABA dosages
timeFrame: 1 year
measure: adherence to ICS therapy
timeFrame: 1 year
measure: Medication Possession Ratio (MPR)
timeFrame: 1 year
measure: Treatment success (definition 2)
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Research in real life
name: David Price
role: PRINCIPAL_INVESTIGATOR
References: