GSK-CTT116853

Study Sponsor: GSK

Study Title

A Phase III, 24 Week, Randomized, Double Blind, Double Dummy, Parallel Group Study (with an Extension to 52 Weeks in a Subset of Subjects) Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination FF/UMEC/VI Administered Once Daily in the Morning via a Dry Powder Inhaler with Budesonide/Formoterol 400mcg/12mcg Administered Twice-Daily via a Reservoir Inhaler in Subjects with Chronic Obstructive Pulmonary Disease

Medicine or Vaccine (generic name)

fluticasone furoate/vilanterol/umeclidinium bromide

Sponsor Identification Number

CTT116853

Trial Registry Identification Number(#'s)

NCT02345161 2013-003073-10

Medical Condition

Pulmonary Disease, Chronic Obstructive

Phase

Phase 3

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=116853

Link to study details on ClinicalTrials.gov (if available)

http://clinicaltrials.gov/show/NCT02345161

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-003073-10

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

This study is available in CDISC format

Date Added to this Site

September 2017