Improved daytime spirometric efficacy of tiotropium compared with salmeterol in patients with COPD

Pulm Pharmacol Ther. 2005;18(6):397-404. doi: 10.1016/j.pupt.2005.02.013. Epub 2005 Apr 25.


Background: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommends long-acting bronchodilators as first-line maintenance treatment for patients with chronic obstructive pulmonary disease (COPD). A study was conducted comparing the long-acting anticholinergic tiotropium with the long-acting beta-agonist salmeterol to confirm the significant improvements in daytime bronchodilator efficacy seen with tiotropium in previous studies.

Methods: Randomized, double-blind, double-dummy, parallel-group study, comparing daytime bronchodilator efficacy of tiotropium 18 mcg once daily with salmeterol 50 mcg twice daily in patients with COPD. Serial spirometry was performed over 12 h after 12 weeks of treatment. Co-primary endpoints were average (over 12 h) and peak FEV1 at 12 weeks.

Results: 653 patients were randomized (328 tiotropium, 325 salmeterol): mean age 64 years; 66% male; mean baseline FEV1 1.05 l (37.7% predicted). After 12 weeks, the average post-dose FEV1 over 12 h was significantly higher with tiotropium compared with salmeterol (167 vs. 130 mL, respectively, p=0.03), as was peak FEV1 (262 vs. 216 ml, respectively, p=0.01). The average FEV1 responses from 0-6 h and 6-12 h were higher in the tiotropium group compared with salmeterol (p<0.05). Peak and average FVC were significantly higher with tiotropium compared with salmeterol (p<0.01). Morning pre-dose FEV1 responses were not significantly different; however, tiotropium demonstrated a significantly higher pre-dose FVC than salmeterol (p<0.05).

Conclusion: Tiotropium demonstrated significantly greater post-dose improvements in spirometric parameters compared with salmeterol. These improvements were sustained over 12 h.

Publication types

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

MeSH terms

  • Aged
  • Albuterol / analogs & derivatives*
  • Albuterol / pharmacokinetics
  • Albuterol / pharmacology
  • Albuterol / therapeutic use
  • Bronchodilator Agents / pharmacokinetics
  • Bronchodilator Agents / pharmacology*
  • Bronchodilator Agents / therapeutic use*
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Forced Expiratory Volume
  • Humans
  • Male
  • Middle Aged
  • Pulmonary Disease, Chronic Obstructive / drug therapy*
  • Salmeterol Xinafoate
  • Scopolamine Derivatives / pharmacokinetics
  • Scopolamine Derivatives / pharmacology*
  • Scopolamine Derivatives / therapeutic use*
  • Tiotropium Bromide
  • Treatment Outcome


  • Bronchodilator Agents
  • Scopolamine Derivatives
  • Salmeterol Xinafoate
  • Albuterol
  • Tiotropium Bromide