GSK-207609

Study Sponsor: GSK

Study Title

A Phase IV, 12-week, randomised, double-blind, triple dummy study to compare single inhaler triple therapy, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) with multiple inhaler therapy (budesonide/formoterol plus tiotropium) based on lung function and symptoms in participants with chronic obstructive pulmonary disease

Medicine or Vaccine (generic name)

fluticasone furoate/vilanterol/umeclidinium bromid

Sponsor Identification Number

207609

Trial Registry Identification Number(#'s)

NCT03478696 2017-001150-33

Medical Condition

Pulmonary Disease, Chronic Obstructive

Phase

Phase 4

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=207609

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

http://clinicaltrials.gov/show/NCT03478696

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=/2017-001150-33

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

An annotated case report form is not available for this study. A blank case report form will be provided. This study is available in CDISC format.

Date Added to this Site

July 2020