Efficacy of salmeterol xinafoate in the treatment of COPD

Chest. 1999 Apr;115(4):957-65. doi: 10.1378/chest.115.4.957.


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 < or = 65% predicted and no clinically significant concurrent disease.

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

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Adrenergic beta-Agonists / administration & dosage*
  • Adrenergic beta-Agonists / adverse effects
  • Albuterol / administration & dosage
  • Albuterol / adverse effects
  • Albuterol / analogs & derivatives*
  • Bronchodilator Agents / administration & dosage*
  • Bronchodilator Agents / adverse effects
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Forced Expiratory Volume
  • Humans
  • Ipratropium / administration & dosage
  • Lung Diseases, Obstructive / drug therapy*
  • Lung Diseases, Obstructive / physiopathology
  • Male
  • Middle Aged
  • Quality of Life
  • Salmeterol Xinafoate
  • Vital Capacity


  • Adrenergic beta-Agonists
  • Bronchodilator Agents
  • Salmeterol Xinafoate
  • Ipratropium
  • Albuterol