Real-world Effectiveness of Combination Therapies in Primary Care Asthma Management (Fos/Ser_switch)

Research in Real-Life

Status: Completed

Conditions: Asthma

Treatments: Drug: Fixed-dose combination beclometasone dipropionate / formoterol; Drug: Fixed dose combination salmeterol / fluticasone

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT01242098

004/11

Details and patient eligibility

About

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.

Enrollment: 137 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

137 participants in 2 patient groups

Fostair switch cohort

Description:

Seretide patients who, at an index date, had a step down in therapy (reduction in ICS dose of ≥50%) and switch to Fostair

Treatment:

Drug: Fixed-dose combination beclometasone dipropionate / formoterol

Seretide continuation cohort

Description:

Seretide patients who, at an index date, had a step down in therapy (reduction in ICS dose of ≥50%) and continue on Seretide

Treatment:

Drug: Fixed dose combination salmeterol / fluticasone