The Purpose of This Study is to Evaluate the Spirometric Effect (Trough FEV1) of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily Compared With Tiotriopium 18 mcg Once Daily Over a 24-week Treatment Period in Subjects With COPD

Summary

The purpose of this 24 week study is to evaluate the spirometric lung function effect (trough FEV1) of Umeclidinium/Vilanterol 62.5/25 once daily compared to Tiotropium 18 mcg once daily along with safety assessments in subjects with COPD.

Timeline

Start

2013-01-23

Primary completion

2013-09-24

Completion

2013-09-24

Outcome

Met primary endpoint

registry UMEC/VI 62.5/25 µg vs TIO 18 µg; p <0.001; Least squares mean difference 0.112 (95% CI 0.081 to 0.144); Mixed Models Analysis NCT01777334 ↗

paper UMEC/VI improved trough FEV1 versus TIO at day 169 [least squares mean (95% confidence interval): MN: 146 ml (102-189) and ITT: 95 ml (71-118); both P <0.001]. PMID 27796912 ↗

Publications

• Maleki-Yazdi MR, Singh D, Anzueto A, Tombs L, Fahy WA, Naya I. Assessing Short-term Deterioration in Maintenance-naive Patients with COPD Receiving Umeclidinium/Vilanterol and Tiotropium: A Pooled Analysis of Three Randomized Trials. Adv Ther. 2017 Jan;33(12):2188-2199. doi: 10.1007/s12325-016-0430-6. Epub 2016 Oct 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Tiotropium	Other / unclassified	18 ug	Inhaled
Subject	Umeclidinium	Other / unclassified	62.5 ug	Inhaled
Subject	Vilanterol	Other / unclassified	25 ug	Inhaled

Indications