Salbutamol via Easyhaler (R) produces equivalent bronchodilation to terbutaline via Turbuhaler (R) following inhalation of a single dose of equipotent beta(2)-sympathomimetic
A. Malinen et al., Salbutamol via Easyhaler (R) produces equivalent bronchodilation to terbutaline via Turbuhaler (R) following inhalation of a single dose of equipotent beta(2)-sympathomimetic, CLIN DRUG I, 20(3), 2000, pp. 165-171
Objective: The aim of this study was to compare the bronchodilating effect,
tolerability and acceptability of a single 100 mu g dose of salbutamol inh
aled via Easyhaler(R) multidose dry powder inhaler with a single 250 mu g d
ose of terbutaline inhaled via Turbuhaler(R), also a multidose dry powder i
nhaler.
Design, Setting and Patients: The study was conducted according to a single
-dose, crossover, randomised, double-blind with double-dummy design in four
centres in Finland. A total of 29 adult patients with stable asthma withou
t previous experience with the tested devices completed the study, which co
mprised 2 study days with if-hour follow-up periods including spirometric m
easurements. The acceptability of the devices to the patients in the study
was also evaluated.
Results: The mean (SD) maximum value of forced expiratory volume in 1 secon
d (FEV1max) after salbutamol Easyhaler(R) was 3.14L(1.26L), and after terbu
taline Turbuhaler(R) was 3.07L(1.11L). The mean (SD) percentage change from
baseline of forced expiratory volume in 1 second (FEV1) to FEV1max was 12.
7% (12.4%) after Easyhaler(R) and 13.1% (10.8%) after Turbuhaler(R). The ob
served differences in the increase in FEV 1 and in the area under the curve
(AUC) of FEV1 between the treatments were not statistically significant. F
our patients reported mild adverse events after inhaling salbutamol via Eas
yhaler(R), compared with five patients who reported adverse events after in
haling terbutaline via Turbuhaler(R). Based on the VAS assessment of the ac
ceptability, Easyhaler(R) was found to be better accepted than Turbuhaler(R
) in terms of ease of administration, ease of inhaling, and the strength of
sensation on receiving a dose. Overall, 62% of the patients would have cho
sen Easyhaler(R).
Conclusions: Easyhaler(R) containing salbutamol (100 mu g/dose) is comparab
le in efficacy and as well tolerated as Turbuhaler(R) containing terbutalin
e (250 mu g/dose), and Easyhaler(R) was well accepted by patients.