Salmeterol may be useful in the treatment of asthmatic patients requir
ing high-dose inhaled steroids, and there have been debates about its
anti-inflammatory action. We have compared the efficacy and effects on
serum inflammatory markers, including soluble interleukin 2R (sIL-2R)
, eosinophil cationic protein (ECP), and tryptase of salmeterol and al
buterol in 20 patients with moderate to severe asthma who were all rec
eiving high-dose inhaled corticosteroids and inhaled beta(2)-agonist o
n demand. After a e-week run-in period, they received, in a randomized
, crossover, double-blind and placebo-controlled manner, either salmet
erol, 50 mu g twice a day, or albuterol 400 mu g, four times a day, fr
om a powder inhaler during two 2-week treatment periods, separated by
a 2-week washout. Compared with albuterol, salmeterol treatment was as
sociated with better morning and mean peak expiratory flow (p=0.013 an
d 0.016, respectively), less daytime and nocturnal symptoms (p=0.008 a
nd 0.01, respectively), reduced requirement of rescue albuterol (p=0.0
4), and better efficacy rating by patients (p=0.04). However, serum co
ncentration of sIL-2R was significantly higher during regular albutero
l treatment (p=0.014) but no differences were seen in the concentratio
ns of ECP and tryptase between the two treatment periods. We conclude
that inhaled salmeterol, 50 mu g twice daily, confers a better control
of asthma than albuterol, 400 mu g four times daily, in patients with
moderate to severe disease, and the latter treatment may be associate
d with increased T-lymphocyte activation.