A Study to Compare the Impact of Fulticasone Furoate/Vilanterol vs. Tiotropium on Arterial Stiffness in COPD

Summary

This study is designed to evaluate the effect of fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) Inhalation Powder once daily (QD) on arterial stiffness compared with Tiotropium QD over 12 week treatment period in subjects with COPD and aortic pulse wave velocity (aPWV) \> 12.0 m/s at Visit 1. Arterial stiffness will be measured as aPWV. This is a comparator, randomised, double-blind, double-dummy, parallel group, multi-centre study. Subjects who meet the eligibility criteria at Screening and meet the randomization criteria at the end of a 2-week Run-In period will enter a 12-week treatment period. There will be an approximate 7-day Follow-up period after the treatment period.

Timeline

Start

2011-06-30

Primary completion

2012-08-01

Completion

2012-08-06

Outcome

Missed primary endpoint

registry analysis (superiority or other test); FF/VI 100/25 µg vs Tiotropium Bromide 18 µg; p = 0.484; Least Squares Mean Difference 0.259 (95% CI -0.468 to 0.986); Mixed Models Analysis NCT01395888 ↗

paper The mean difference in aPWV between FF/VI and TIO at week 12 was not significant (P = .484). PMID 25058845 ↗

Publications

• Pepin JL, Cockcroft JR, Midwinter D, Sharma S, Rubin DB, Andreas S. Long-acting bronchodilators and arterial stiffness in patients with COPD: a comparison of fluticasone furoate/vilanterol with tiotropium. Chest. 2014 Dec;146(6):1521-1530. doi: 10.1378/chest.13-2859.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fluticasone Furoate	Other / unclassified	100 ug	Inhaled
Comparator	Tiotropium	Other / unclassified	18 ug	Inhaled
Subject	Vilanterol	Other / unclassified	25 ug	Inhaled

Indications