Efficacy of salmeterol xinafoate in the treatment of COPD

Study objectives: To examine and compare the efficacy and safety of salmeterol xinafoate, a long-acting inhaled beta(2)-adrenergic agonist, with inhaled ipratropium bromide and inhaled placebo in patients with COPD, Design: A stratified, randomized, double-blind, double-dummy, placebo-controlled, parallel group clinical trial. Setting: Multiple sites at clinics and 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 disease. Interventions: Comparison of inhaled salmeterol (42 mu g twice daily), inhaled 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 placebo and ipratropium in improving lung function at the recommended doses over the 12-week trial. Both salmeterol and ipratropium reduced dyspnea related to activities of daily living compared with placebo; this improvement was associated with reduced use of supplemental albuterol, Analyses of time to first COPD exacerbation revealed salmeterol to be superior to placebo and ipratropium (p < 0.05), Adverse effects were similar among the three treatments. Conclusions: These collective data support the use of salmeterol as first-line bronchodilator therapy for the long-term treatment of airflow obstruction in patients with COPD.