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.
Study Type
OBSERVATIONAL
Enrollment
137
Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy
Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy
Optimum Patient Care
Cawston, Norfolk, United Kingdom
Exacerbation rate
Where an exacerbation is defined as: (i) Asthma-related 1. Hospital attendance / admissions OR 2. Accident \& Emergency (A\&E) attendance OR (ii) Use of oral steroids.
Time frame: One-year outcome period
Exacerbation control (a composite proxy measure)
Controlled: Absence of: (i) Asthma-related: 1. Hospital attendance or admission 2. A\&E attendance, OR 3. Out of hours consultations, OR 4. Out-patient department attendance (ii) GP consultations for lower respiratory tract infection (iii) Prescriptions for acute courses of oral steroids
Time frame: 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).
Time frame: One-year outcome period
Asthma hospitalisations
1. Definite: Hospitalisations coded with an asthma read code 2. 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
Time frame: One-year outcome period
Compliance with ICS/LABA therapy
Compliance calculation based on prescription refills and (where possible) compliance questionnaire data
Time frame: 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.
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Time frame: 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
Time frame: One-year outcome period
Asthma-related / respiratory hospitalisations
1. Definite: Hospitalisations coded with a lower respiratory code 2. 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
Time frame: one year outcome period
Oral Thrush
Identified as: (i) Topical oral anti-fungal prescriptions, and / or (ii) Coded for oral candidiasis
Time frame: One-year outcome period