SERETIDE Plus Tiotropium Versus Individual Components

Phase 2 Completed 41 enrolled GlaxoSmithKline

RandomizedCrossoverDouble-blindTreatment

Summary

This study was designed to evaluate the effects on lung function of a combination of SERETIDE 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments (tiotropium bromide 18mcg once daily alone and SERETIDE 50/500mcg twice daily alone) in subjects with COPD. The study will utilise a three-way cross-over design with a 2-week wash-out period between each 2-week consecutive treatment period.

Timeline

Start: 2005-12
Primary completion: 2006-08
Completion: 2006-08

Outcome

Met primary endpoint

paper AUC(0-4 h) sGaw was significantly higher on day 14 after SFC+TIO compared with TIO (22%) or SFC alone (27%) (both p<0.001). PMID 18245142 ↗

Publications

Singh D, Brooks J, Hagan G, Cahn A, O'Connor BJ. Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD. Thorax. 2008 Jul;63(7):592-8. doi: 10.1136/thx.2007.087213. Epub 2008 Feb 1.

Drugs

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