Efficacy of salmeterol xinafoate in the treatment of COPD

Study objectives: To examine and compare the efficacy and safety of salmete rol xinafoate, a long-acting inhaled beta(2)-adrenergic agonist, with inhal ed ipratropium bromide and inhaled placebo in patients with COPD, Design: A stratified, randomized, double-blind, double-dummy, placebo-contr olled, parallel group clinical trial. Setting: Multiple sites at clinics an d university medical centers throughout the United States. Patients: Four hundred eleven symptomatic patients with COPD with FEV1 less than or equal to 05% predicted and no clinically significant concurrent di sease. Interventions: Comparison of inhaled salmeterol (42 mu g twice daily), inha led ipratropium bromide (36 mu g four times a day), and inhaled placebo (2 puffs four times a day) over 12 weeks. Results: Salmeterol xinafoate was significantly (p < 0.0001) better than pl acebo and ipratropium in improving lung function at the recommended doses o ver the 12-week trial. Both salmeterol and ipratropium reduced dyspnea rela ted to activities of daily living compared with placebo; this improvement w as associated with reduced use of supplemental albuterol, Analyses of time to first COPD exacerbation revealed salmeterol to be superior to placebo an d ipratropium (p < 0.05), Adverse effects were similar among the three trea tments. Conclusions: These collective data support the use of salmeterol as first-l ine bronchodilator therapy for the long-term treatment of airflow obstructi on in patients with COPD.