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

Study Overview
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Brief Summary
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The purpose of this study is 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.

Official Title
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Retrospective, Real-life Observational, Matched Cohort Evaluation of the Effectiveness of BDP/FOR (Fostair® 100/6) and FP/SAL (Seretide® 125) in Patients Switching From Seretide to Fostair in UK Primary Care Asthma Management

Conditions
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Asthma

Intervention / Treatment
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* Drug: Fixed dose combination salmeterol / fluticasone
* Drug: Fixed-dose combination beclometasone dipropionate / formoterol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged: 18-60 years: 61-80 years who are never-smokers Evidence of asthma: a diagnostic code for asthma, or ≥2 prescriptions for asthma at different points in time during the prior year Baseline FP/SAL therapy: ≥2 prescription for ICS/LABA therapy as FP/SAL (Seretide® 125). Exclusion Criteria: Any chronic respiratory disease other than asthma Are receiving maintenance oral steroid therapy during baseline period.

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fostair switch cohort<br>Seretide patients who, at an index date, had a step down in therapy (reduction in ICS dose of ≥50%) and switch to Fostair | Drug: Fixed-dose combination beclometasone dipropionate / formoterol<br>* Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy<br>* Other names: BDP/FOR; Fostair® 100/6;|
| Seretide continuation cohort<br>Seretide patients who, at an index date, had a step down in therapy (reduction in ICS dose of ≥50%) and continue on Seretide | Drug: Fixed dose combination salmeterol / fluticasone<br>* Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy<br>* Other names: FP/SAL; Seretide® 125;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exacerbation rate | Where an exacerbation is defined as: (i) Asthma-related Hospital attendance / admissions OR Accident & Emergency (A&E) attendance OR (ii) Use of oral steroids. | One-year outcome period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exacerbation control (a composite proxy measure) | Controlled: Absence of: (i) Asthma-related: Hospital attendance or admission A&E attendance, OR Out of hours consultations, OR Out-patient department attendance (ii) GP consultations for lower respiratory tract infection (iii) Prescriptions for acute courses of oral steroids | One-year outcome period | 
| Treatment success 1 | (i) Exacerbation control AND (ii) No change in therapeutic regimen: ≥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). | One-year outcome period | 
| Asthma hospitalisations | 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 | One-year outcome period | 
| Compliance with ICS/LABA therapy | Compliance calculation based on prescription refills and (where possible) compliance questionnaire data | One-year outcome period | 
| Use of reliever medication | average daily dosage during outcome year. Outcome SABA usage will be categorised within ranges used to match baseline SABA use to optimise matching of the treatment arms. | One-year outcome period | 
| Cost of therapeutic regimen. | Mean healthcare costs (drug costs + consultation, admission costs, etc - total and respiratory-related) per patient recorded during the outcome year | One-year outcome period | 
| Asthma-related / respiratory hospitalisations | Definite: Hospitalisations coded with a lower respiratory code 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 | one year outcome period | 
| Oral Thrush | Identified as: (i) Topical oral anti-fungal prescriptions, and / or (ii) Coded for oral candidiasis | One-year outcome period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Combination therapy, Primary care management, Switch, ICS/LABA, Fostair, Seretide