Efficacy of Salmeterol Xinafoate in the Treatment of COPD*.
Mahler, Donald A. MD, FCCP; Donohue, James F. MD, FCCP; Barbee, Robert A. MD, FCCP; Goldman, Michael D. MD; Gross, Nicholas J. MD, FCCP; Wisniewski, Michael E. PhD; Yancey, Steven W. MS; Zakes, Bradford A. MS; Rickard, Kathleen A. MD; Anderson, Wayne H. PhD
[Article] Chest. 115(4):957-965, April 1999.

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Study objectives: To examine and compare the efficacy and safety of salmeterol xinafoate, a long-acting inhaled beta2-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

Interventions: Comparison of inhaled salmeterol (42 [micro sign]g twice daily), inhaled ipratropium bromide (36 [micro sign]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.

(CHEST 1999; 115:957-965)

Copyright (C) 1999 by the American College of Chest Physicians