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

Research in Real-Life

Status: Completed

Conditions: Asthma

Treatments: Drug: FP/SAL; Drug: BDP/FOR

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT01908075

R04312

Details and patient eligibility

About

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.

Full 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).

Enrollment: 194,723 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

194,723 participants in 2 patient groups

BDP/FOR

Description:

Patients receiving ICS/LABA therapy as FP/SAL (Seretide®) who, at an index prescription date (IPD): Change their therapy to BDP/FOR (Fostair®) at same or lower BDP-equivalent ICS dose

Treatment:

Drug: BDP/FOR

Drug: FP/SAL

FP/SAL

Description:

Patients receiving ICS/LABA therapy as FP/SAL (Seretide®) who, at an index prescription date (IPD) : Remain on FP/SAL at the same BDP-equivalent ICS dose

Treatment:

Drug: FP/SAL