Effectiveness and Safety of Salmeterol in Nonspecialist Practice Settings

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