Real Life Effectiveness of Easyhaler (Orion)

NCT02048930 | Completed

• 1 other identifier: R02411
• Study Type: observational
• Target: 24,003
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Keywords

GPRD; effectiveness; cost-effectiveness; Easyhaler; Primary care; DPI

Outcome Measures

Primary Outcomes (4)

• 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 : 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.

  1 year

• exacerbations (ATS definition)

  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.

  1 year

• exacerbations (Clinical definition)

  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.

  1 year

• 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 : 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.

  1 year

Secondary Outcomes (5)

• treatment success definition 1

  1 year

• SABA dosages

  1 year

• adherence to ICS therapy

  1 year

• Medication Possession Ratio (MPR)

  1 year

• Treatment success (definition 2)

  1 year

Study Arms (3)

Initiation cohort

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

Device: Budesonide Easyhaler; Device: Budesonide dry powder inhaler

Step-up cohort

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

Device: Budesonide Easyhaler; Device: Budesonide dry powder inhaler

Switch cohort

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

Device: Budesonide Easyhaler; Device: Budesonide dry powder inhaler

Interventions

Budesonide Easyhaler DEVICE

Initiation cohort; Step-up cohort; Switch cohort

Budesonide dry powder inhaler DEVICE

Initiation cohort; Step-up cohort; Switch cohort

Eligibility Criteria

• Age: 6 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• (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:
• Initiation - a diagnostic code for asthma
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research in Real-Life Ltd: lead
• Orion Corporation, Orion Pharma: collaborator

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• David Price

  Research in real life

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 29, 2014
• Study Start: September 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: January 29, 2014

Record last verified: 2014-01