Effect of Tiotropium Plus Salmeterol vs. Fluticasone/Salmeterol on Static Lung Volumes and Exercise Endurance in COPD

Summary

The primary objective of this study is to demonstrate that treatment with a free combination of tiotropium and salmeterol provides superior improvement in static lung volumes and exercise tolerance compared to a fixed combination of fluticasone and salmeterol in patients with COPD. The secondary objective includes assessment of safety.

Timeline

Start

2007-09

Primary completion

2009-01

Completion

—

Outcome

Mixed primary results

registry analysis (superiority or other test); Tiotropium + Salmeterol vs Fluticasone + Salmeterol; p = 0.0482; Mean Difference (Final Values) -0.087 (95% CI -0.174 to -0.001); ANOVA NCT00530842 ↗

paper Relative to S + F, T + S lowered postdose TGV by 182 ± 44 ml after 4 weeks (p < 0.0001) and 87 ± 44 ml after 8 weeks (p < 0.05). PMID 22749044 ↗

registry analysis (superiority or other test); Tiotropium + Salmeterol vs Fluticasone + Salmeterol; p = 0.3407; Median Difference (Final Values) 3.0 (95% CI -9.5 to 27.5); Wilcoxon signed-rank test NCT00530842 ↗

paper EET was nonsignificantly increased following T + S treatment (20 ± 15 s at 4 weeks, 15 ± 13 s at 8 weeks) vs. S + F. PMID 22749044 ↗

Publications

• Magnussen H, Paggiaro P, Schmidt H, Kesten S, Metzdorf N, Maltais F. Effect of combination treatment on lung volumes and exercise endurance time in COPD. Respir Med. 2012 Oct;106(10):1413-20. doi: 10.1016/j.rmed.2012.05.011. Epub 2012 Jun 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fluticasone	Other / unclassified	500 ug	Inhaled
Subject	Salmeterol	Other / unclassified	50 ug	Inhaled
Subject	Tiotropium	Other / unclassified	18 ug	Inhaled

Indications