Effectiveness and safety of salmeterol in nonspecialist practice settings

Study objectives: To evaluate the effectiveness and safety of inhaled salme terol in patients managed in nonspecialist practice settings. 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 Th oracic Society asthma criteria were enrolled and randomized to treatment wi th either twice-daily salmeterol aerosol (50 mug; n = 455) or matching plac ebo twice daily (n = 456). Both groups were allowed to take salbutamol as n eeded. All subjects were previously treated with anti-inflammatory maintena nce therapy that was continued throughout the study. Measurement and results: The primary outcome variable was: the proportion o f subjects with serious asthma exacerbations defined As an exacerbation req uiring hospitalization, emergency department visit, or use of prednisone du ring the treatment period. A total of 712 subjects competed the study. Ther e 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 sign ificantly higher in the salmeterol group (398 L/min vs 386 L/min for placeb o; p < 0.01). Median daily use of salbutamol was two inhalations for the sa lmeterol group and three inhalations for placebo (p < 0.001). The proportio n of subjects sleeping through the night was: significantly higher in the s almeterol group, (74%) as compared to placebo (88%; 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 sev ere exacerbations.