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(Chest. 1999;115:957-965.)
© 1999 American College of Chest Physicians

Efficacy of Salmeterol Xinafoate in the Treatment of COPD*

Donald A. Mahler, MD, FCCP; James F. Donohue, MD, FCCP; Robert A. Barbee, MD, FCCP; Michael D. Goldman, MD; Nicholas J. Gross, MD, FCCP; Michael E. Wisniewski, PhD; Steven W. Yancey, MS; Bradford A. Zakes, MS; Kathleen A. Rickard, MD and Wayne H. Anderson, PhD

* From Dartmouth Medical School (Dr. Mahler), Lebanon, NH; University of North Carolina (Dr. Donohue), Chapel Hill, NC; Arizona Medical Center (Dr. Barbee), Tucson, AZ; University of California (Dr. Goldman), Los Angeles, CA; Hines VA Hospital (Dr. Gross), Hines, IL; and Glaxo Wellcome Inc (Drs. Wisniewski, Rickard, and Anderson, and Messrs. Yancey and Zakes), Research Triangle Park, NC. Supported by Glaxo Wellcome Inc, Research Triangle Park, NC.

Study objectives: To examine and compare the efficacy and safety of salmeterol xinafoate, a long-acting inhaled ß2-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 <= 65% predicted and no clinically significant concurrent disease.

Interventions: Comparison of inhaled salmeterol (42 µg twice daily), inhaled ipratropium bromide (36 µg 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.

Key Words: chronic obstructive pulmonary disease • dyspnea • inhaled ß2-agonists • ipratropium • salmeterol




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