A Six-week Study Comparing the Efficacy and Safety of Tiotropium Plus Formoterol to Salmeterol Plus Fluticasone in Chronic Obstructive Pulmonary Disease (COPD)

Summary

To compare the efficacy and safety of tiotropium plus formoterol in comparison to salmeterol plus fluticasone in COPD patients.

Timeline

Start

2003-11

Primary completion

2004-09

Completion

2004-09

Outcome

Met primary endpoint

paper the group receiving tiotropium plus formoterol were superior to those in the group receiving salmeterol plus fluticasone PMID 18403672 ↗

paper mean difference in FEV(1) AUC(0-12), 78 mL [p = 0.0006] PMID 18403672 ↗

paper difference in peak FEV(1), 103 mL [p < 0.0001] PMID 18403672 ↗

Publications

• Rabe KF, Timmer W, Sagkriotis A, Viel K. Comparison of a combination of tiotropium plus formoterol to salmeterol plus fluticasone in moderate COPD. Chest. 2008 Aug;134(2):255-262. doi: 10.1378/chest.07-2138. Epub 2008 Apr 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fluticasone propionate	Other / unclassified	500 ug	Inhaled
Subject	Formoterol	Other / unclassified	12 ug	Inhaled
Subject	Salmeterol	Other / unclassified	50 ug	Inhaled
Subject	Tiotropium	Other / unclassified	18 ug	Inhaled

Indications