This was a 4-week, open-label, parallel-group study designed to compar
e the efficacy and safety of the long-acting inhaled bronchodilator, s
almeterol, with the established inhaled bronchodilator, terbutaline, i
n the treatment of patients with mild to moderate asthma. A total of 2
43 adult patients was randomized to receive treatment with either salm
eterol 50 mu g bd via a Diskhaler(TM) (Glare) inhaler (n = 121)or terb
utaline 500 mu g qds via a reservoir powder inhaler device (n = 122).
Apart from all bronchodilator treatment which was withdrawn at the sta
rt of the run-in period and replaced by inhaled salbutamol to be used
as required for symptom relief, all concurrent medications were kept c
onstant throughout the study. Salmeterol produced a significantly grea
ter increase in mean morning peak expiratory how (PEF) than terbutalin
e (difference in adjusted means after treatment = 28 l/min; 95% CI = 1
9-37 l/min; P<0.001). Likewise, the increase in mean evening PEF was s
ignificantly greater following treatment with salmeterol than with ter
butaline (difference in adjusted means = 9 l/min; 95% CI = 0-17 l/min;
P = 0.045). Salmeterol was associated with a significant reduction in
diurnal variation in PEF by comparison with terbutaline (difference i
n adjusted means = -18 l/min; 95% CI = -24, -12 l/min; P<0.001), Signi
ficant improvements with salmeterol by comparison with terbutaline wer
e also observed in daytime and night-time asthma scores, percentage of
symptom-free days and nights, use of additional inhaled bronchodilato
r, and percentage of days and nights when no additional inhaled bronch
odilator was needed. The greater overall improvement in the control of
asthma and its symptoms after treatment with salmeterol was further e
vident from the lower incidence of asthma-related adverse events in pa
tients taking salmeterol compared with those taking terbutaline (2% an
d 15%, respectively). While both treatments were well tolerated, more
patients withdrew from the terbutaline group than from the salmeterol
group (12 and 3 patients, respectively) and terbutaline was associated
with a higher incidence of drug-related adverse events (26% and 9% in
the terbutaline- and salmeterol-treated groups, respectively). This s
tudy demonstrated that salmeterol 50 mu g bd via a Diskhaler was signi
ficantly more effective and associated with fewer adverse events than
terbutaline 500 mu g qds via a reservoir powder inhaler device.