The aim of the present study was to investigate the efficacy and safety of nebulized fluticasone propionate (FP NebulesTM) compared with oral soluble prednisolone in children with an acute exacerbation of asthma.
The study used an international, multi-centre, randomized, double-blind, parallel group design. Three hundred and twenty-one patients, aged 4–16 years old, who presented with an acute exacerbation of asthma, were randomly allocated to either nebulized FP (1 mg b.d.) or oral prednisolone (2 mg kg−1day−1for 4 days then 1 mg kg−1day−1for 3 days) for 7 days.
Patients in the FP group showed a significantly greater increase in diary card morning peak expiratory flow (PEF) over 7 days compared with patients in the prednisolone group (difference=9·5 l min−1, CI=2·1,16·8, P=0·034). Similar increases for both treatments were shown for evening PEF. Clinic PEF improved with both treatments, but was significantly greater in patients taking FP after 7 days (difference=11·4 lmin−1, CI=2·8, 20·0,P =0·029). Both treatments reduced symptom scores to a similar extent. The two treatments were well tolerated, and there was no difference in the incidence of adverse events.
The present study demonstrated that nebulized FP is at least as effective as oral prednisolone in the treatment of children presenting with an acute exacerbation of asthma.
