Study objectives: To evaluate the effectiveness and
safety of inhaled salmeterol in patients managed in nonspecialist
Design: A randomized, double-blind,
6-month, parallel-group study involving 253 centers.
Setting: Primarily nonspecialist practices
(n = 232).
Patients: A total of 911 subjects
(417 men; 494 women) who met American Thoracic Society asthma criteria
were enrolled and randomized to treatment with either twice-daily
salmeterol aerosol (50 μg; n = 455) or matching placebo twice daily
(n = 456). Both groups were allowed to take salbutamol as needed. All
subjects were previously treated with anti-inflammatory maintenance
therapy that was continued throughout the study.
Measurements and results: The primary outcome variable was
the proportion of subjects with serious asthma exacerbations defined as
an exacerbation requiring hospitalization, emergency department visit,
or use of prednisone during the treatment period. A total of 712
subjects competed the study. There was no significant difference in the
proportion of subjects experiencing serious exacerbations between the
salmeterol and placebo groups (20.8% vs 20.9%, respectively;
p = 0.935; power > 88%). Peak expiratory flow was significantly
higher in the salmeterol group (398 L/min vs 386 L/min for placebo;
p < 0.01). Median daily use of salbutamol was two inhalations for
the salmeterol group and three inhalations for placebo (p < 0.001).
The proportion of subjects sleeping through the night was significantly
higher in the salmeterol group (74%) as compared to placebo (68%;
p = 0.028).
Conclusions: Salmeterol treatment is
effective in subjects typically cared for in the primary-care setting
and does not increase the frequency of severe