Overview

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

Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Research in Real-Life Ltd
Collaborator:
Chiesi Farmaceutici S.p.A.
Treatments:
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Fluticasone-Salmeterol Drug Combination
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