Qvar vs FP in Pediatrics

Research in Real-Life

Status: Completed

Conditions: Asthma

Treatments: Drug: Extra-fine hydrofluoroalkane beclometasone dipropionate; Drug: Fluticasone propionate

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT01877954

R02511

Details and patient eligibility

About

The primary aim of this study was to compare the absolute and relative effectiveness of asthma management in paediatric patients in the UK on inhaled corticosteroid (ICS) maintenance therapy as extra-fine HFA-BDP (Qvar®) pressurised metered dose inhaler (pMDI) compared with fluticasone propionate (FP) pMDI.

Full description

Comparison of asthma control with extrafine-particle hydrofluoroalkane-beclometasone (EF HFA-BDP) vs fluticasone propionate (FP) in paediatric patients (5-11year olds). Patients identified from the General Practice Research Database (GPRD) and the Optimum Patient Care Research Database (OPCRD). Two analyses were conducted:

1. Comparison of outcomes achieved by EF HFA-BDP and FP in 5-6year old patients with those achieved in 7-11yr old patients.
2. Comparison of outcomes achieved by EF HFA-BDP used with or without a spacer to those achieved by standard particle fluticasone propionate (FP) used with a spacer.

Enrollment: 2,654 patients

Sex: All

Ages: 5 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged: 5-11 years
2. Evidence of asthma (diagnostic code and/or current asthma therapy);
3. Have at least one year of up-to-standard (UTS) baseline data (during which the step-up to FP/SAL occurred) and at least one year of UTS outcome data (following the IPD).

Exclusion criteria

1. Had any chronic respiratory disease, except asthma, at any time; and/or
2. Patients on maintenance oral steroids during baseline year

Trial design

2,654 participants in 2 patient groups

IPDI Qvar

Description:

ICS initiation as Extra-fine hydrofluoroalkane beclometasone dipropionate

Treatment:

Drug: Extra-fine hydrofluoroalkane beclometasone dipropionate

IPDI FP

Description:

ICS initiation as fluticasone propionate

Treatment:

Drug: Fluticasone propionate