Seventy-two children (mean age, 10.1 years) with stable moderate asthma who
completed a 7-day run-in period were randomized to receive a 4-week treatm
ent with beclomethasone dipropionate (200 mu g twice daily) administered th
rough two different powder inhalers (Pulvinal; Chiesi Farmaceutici S.p.A, P
arma, Italy and Diskhaler; Glaxo-Wellcome, Evreux, France) in a parallel gr
oup design. Sixty-nine patients completed the study. Morning and evening pe
ak expiratory flow values, the use of rescue salbutamol, and the severity o
f clinical symptoms were recorded daily on a diary card. Pulmonary function
tests were performed at baseline and then after 2 and 4 weeks of treatment
. Pulmonary function values, daily morning and evening peak expiratory flow
, and most of the clinical symptoms significantly improved, although the us
e of rescue salbutamol significantly decreased from the second week of trea
tment until the end of the study in both groups. Equivalence of efficacy be
tween groups was demonstrated for both pulmonary function and clinical para
meters. We conclude that the Pulvinal inhaler is as efficacious as the Disk
haler in beclomethasone-based therapy of asthmatic children.