Asthma
Conditions
Keywords
Primary care, Asthma management, Real-world, Observational, Fostair, Seretide
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).
Interventions
DRUGFP/SAL
DRUGBDP/FOR
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: 18-80 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exacerbations : rate ratio | 1 year | Where an exacerbation is defined as: (i) Asthma-related 1. Hospital attendance / admissions OR 2. 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proxy asthma control + SABA | 1 year | As above, but with an additional criterion that limits controlled patients to those who use ≤200mcg salbutamol daily |
| Treatment success | 1 year | 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). |
| Exacerbation control | 1 year | 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: 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: (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. |
| Hospitalisations | 1 year | 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 |
| Medication possession ratio | 1 year | 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. |
| Asthma Control (including SABA) | 1 year | Defined as proxy asthma control (above) plus: Average daily prescribed dose of ≤200mcg salubtamol / ≤500mcg terbutaline |
Outcome results
None listed