The functional impact of adding salmeterol and tiotropium in patients with stable COPD

M. Cazzola, S. Centanni, P. Santus, M. Verga, M. Mondoni, F. di Marco, M. G. Matera

Research output: Contribution to journalArticlepeer-review

Abstract

The aim of this double-blind, double-dummy, crossover, randomised, pilot study was to explore the acute effects of adding salmeterol and tiotropium in patients with stable COPD. A total of 20 outpatients with stable COPD were enrolled. Single doses of 18-μg tiotropium, 50-μg salmeterol, and 18-μg tiotropium+50-μg salmeterol were given. Serial measurements of forced expiratory volume in 1 s (FEV1) were performed over 24 h. The mean maximum increases in FEV1 from pre-dosing value on each of the dosing days were 0.165 l (95% CI: 0.098-0.232) for tiotropium, 0.241 l (95% CI: 0.151-0.332) for salmeterol, and 0.290 l (95% CI: 0.228-0.353) for the combination and occurred 4 h after inhalation of tiotropium or salmeterol and 3 h after the combination. At 12 h, the mean increases in FEV1 from pre-dosing value were 0.071 l (95% CI: 0.001-0.141; P=0.047) for tiotropium, 0.069 l (95% CI: 0.018-0.120; P=0.010) for salmeterol, and 0.108 l (95% CI: 0.047-0.170; P=0.001) for the tiotropium+salmeterol combination. Only the difference between salmeterol and tiotropium+salmeterol was statistically significant (P=0.009). At 24 h, the mean FEV1 value was still higher than the mean pre-dosing value for tiotropium (0.042 l; 95% CI: -0.012-0.097; P=0.119) and the tiotropium+salmeterol combination (0.051 l; 95% CI: 0.015-0.087; P=0.007), but not for salmeterol alone (-0.013 l; 95% CI: -0.041-0.014; P=0.324). The FEV1 area under the curve (AUCs0-12h) were 1.657 l (95% CI: 1.152-2.162) for tiotropium, 2.068 l (95% CI: 1.385-2.752) for salmeterol, and 2.541 l (95% CI: 1.954-3.129) for tiotropium+salmeterol. Only the difference between tiotropium and the tiotropium+salmeterol combination was statistically significant (P=0.01). The FEV1 AUCs0-24h were 2.854 l (95% CI: 1.928-3.780) for tiotropium, 2.786 l (95% CI: 1.913-3.660) for salmeterol, and 3.640 l (95% CI: 2.674-4.605) for tiotropium+salmeterol. All differences between treatments were not statistically significant (P>0.05). These results seem to indicate that the use of the tiotropium+salmeterol combination is more efficacious than the single agents alone, but the once-daily administration of the two drugs is inadvisable due to the broncholytic profile of salmeterol.

Original languageEnglish
Pages (from-to)1214-1221
Number of pages8
JournalRespiratory Medicine
Volume98
Issue number12
DOIs
Publication statusPublished - Dec 2004

Keywords

  • Combination therapy
  • COPD
  • Salmeterol
  • Tiotropium

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

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