Asthma
Conditions
Keywords
Asthma, Combination therapy, Primary care management, Switch, ICS/LABA, Fostair, Seretide
Brief summary
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.
Interventions
DRUGFixed dose combination salmeterol / fluticasone
Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy
DRUGFixed-dose combination beclometasone dipropionate / formoterol
Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy
Sponsors
Chiesi Farmaceutici S.p.A.
Research in Real-Life Ltd
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exacerbation rate | One-year outcome period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment success 1 | One-year outcome period | (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). |
| Asthma hospitalisations | One-year outcome period | 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 |
| Compliance with ICS/LABA therapy | One-year outcome period | Compliance calculation based on prescription refills and (where possible) compliance questionnaire data |
| Exacerbation control (a composite proxy measure) | One-year outcome period | 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 |
| Cost of therapeutic regimen. | One-year outcome period | Mean healthcare costs (drug costs + consultation, admission costs, etc - total and respiratory-related) per patient recorded during the outcome year |
| Asthma-related / respiratory hospitalisations | one year outcome period | 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 |
| Oral Thrush | One-year outcome period | Identified as: (i) Topical oral anti-fungal prescriptions, and / or (ii) Coded for oral candidiasis |
| Use of reliever medication | One-year outcome period | 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. |
Countries
United Kingdom
Outcome results
None listed