Real-world Effectiveness of Combination Therapies in Primary Care Asthma Management

Study Overview
=================
Brief Summary
-----------------
To evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol (FP/SAL; Seretide® 125) in matched asthma patients switching to BDP/FOR following treatment with FP/SAL in normal clinical practice compared with patients not switched.

Detailed Description
-----------------
To evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol (FP/SAL; Seretide®) in matched asthma patients switching to BDP/FOR following treatment with FP/SAL in normal clinical practice compared with patients not switched. To evaluate respiratory outcomes for Fostair in comparison to Seretide using a UK primary care database (in patients switched for cost rather than clinical reasons).

Official Title
-----------------
REACH Fostair vs Seretide - Real-world Effectiveness of Combination Therapies in Primary Care Asthma Management

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: FP/SAL
* Drug: BDP/FOR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged: 18-80 years 61-80 years to be non-smokers only Evidence of asthma: a diagnostic code for asthma or two scripts for asthma.. Baseline FP/SAL therapy: ≥2 prescription for ICS/LABA therapy as FP/SAL Evidence of Continuing Therapy: Include only patients who receive ≥2 prescriptions for the therapy under study during the outcome year (i.e. ≥1 prescription at the index date and ≥1 other). UK average is 3-4 prescriptions refilled per year, so ≥2 ensures capture of real-life data. Evidence of Switching for economic reasons: FP/SAL patients from practices with ≥5 switches to Fostair in a 3 month period to minimise data taken from switching of anomalous patients; optimal practices for inclusion are those switching wholesale for economic reasons. Exclusion Criteria: Any chronic respiratory disease other than asthma Are receiving maintenance oral steroid therapy during baseline period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BDP/FOR<br>Patients receiving ICS/LABA therapy as FP/SAL (Seretide®) who, at an index prescription date (IPD): Change their therapy to BDP/FOR (Fostair®) at same or lower BDP-equivalent ICS dose | Drug: FP/SAL<br> <br> * Other names: Seretide®;Drug: BDP/FOR<br> <br> * Other names: Fostair® 100/6;|
| FP/SAL<br>Patients receiving ICS/LABA therapy as FP/SAL (Seretide®) who, at an index prescription date (IPD) : Remain on FP/SAL at the same BDP-equivalent ICS dose | Drug: FP/SAL<br> <br> * Other names: Seretide®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exacerbations : rate ratio | Where an exacerbation is defined as: (i) Asthma-related Hospital attendance / admissions OR Accident & Emergency (A&E) attendance OR (ii) Use of acute oral steroids. Where: ≥1 oral steroid prescription occurs within 2 weeks of another, or ≥1 hospitalisation occurs within 2 weeks of another, or ≥1 hospitalisation occurs within 2 weeks of an oral steroid prescription | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exacerbation control | Proxy Asthma Control. The absence of exacerbation and the absence of antibiotic prescribing for lower respiratory tract infections (often a pragmatic prescribing decision taken by GPs in real world practice). Controlled: (i) No 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: (i) All others. a. Proxy Asthma Control + SABA As above, but with an additional criterion that limits controlled patients to those who use ≤200mcg salbutamol daily. | 1 year | 
| Proxy asthma control + SABA | As above, but with an additional criterion that limits controlled patients to those who use ≤200mcg salbutamol daily | 1 year | 
| Treatment success | No exacerbation and no change in therapy during the outcome year, where changes are: •≥50% increase in ICS dose relative to IPD dose, and/or Change in ICS/LABA drug within class, and/or Change in delivery device, and/or Use of additional (defined as not received during baseline year) therapy as defined by: theophylline, leukotriene receptor antagonists (LTRAs). | 1 year | 
| Asthma Control (including SABA) | Defined as proxy asthma control (above) plus: Average daily prescribed dose of ≤200mcg salubtamol / ≤500mcg terbutaline | 1 year | 
| Hospitalisations | Asthma-related hospitalizations Definite: Hospitalisations coded with an asthma read code Definite + Probable: Hospitalisations with an asthma read code + uncoded hospitalisations occurring within a 7-day window (either side of the hospitalisation date) of an asthma read code Respiratory hospitalisations Definite: Hospitalisations coded with a lower respiratory code relevant for Paeds (for example J450) Definite + Probable: Hospitalisations with an asthma read code + uncoded hospitalisations occurring within a 7-day window (either side of the hospitalisation date) of a lower respiratory read code | 1 year | 
| Medication possession ratio | For ICS, defined as the number of days supply of ICS / 365 x 100% Controller/reliever ratio: number of controller units/ number of controller units + number of reliever units. Controllers are defined as ICS (including fixed combination ICS/LABA) and LTRA, while relievers are SABA. For ICS a unit is taken to be one inhaler; for LTRA a unit is one prescription. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary care, Asthma management, Real-world, Observational, Fostair, Seretide