NCT03474081 - A Comparative Study Between Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy Versus Tiotropium Monotherapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD) | Biotech Hunter

Enrollment

800

Participants

Timeline

Start Date

March 29, 2018

Primary Completion Date

July 17, 2019

Study Completion Date

July 17, 2019

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

FF/UMEC/VI

A single inhaler triple therapy of FF/UMEC/VI will be provided via ELLIPTA DPI. FF/UMEC/VI will be available as dry white powder with dosing strengths of 100/25/62.5 mcg per blister.

DRUG

Tiotropium

Tiotropium will be provided as a hard gelatin capsule for oral inhalation containing 18 mcg tiotropium bromide blended with lactose, administered via HANDIHALER DPI.

DRUG

Albuterol/salbutamol

Albuterol/salbutamol will be provided as an inhalation via MDI with a spacer or nebules and will be given as a rescue medication throughout the study.

DRUG

Placebo to match FF/UMEC/VI

Placebo matching FF/UMEC/VI will be available as a dry white powder of lactose or magnesium stearate, administered via ELLIPTA DPI.

DRUG

Placebo to match tiotropium

Placebo will be given as hard gelatin capsule for oral inhalation containing lactose, administered via HANDIHALER DPI.

DEVICE

ELLIPTA inhaler

ELLIPTA DPI will contain two individual blister strips with 30 blisters per strip. FF/UMEC/VI and placebo to match FF/UMEC/VI will be administered to the subjects using ELLIPTA DPI.

DEVICE

HANDIHALER

Tiotropium and placebo to match tiotropium will be administered to the subjects using HANDIHALER DPI.

DEVICE

MDI

Albuterol/salbutamol will be provided as a rescue medication throughout the study using MDI.

Trial Locations (72)

10708

GSK Investigational Site, Bronxville

13066

GSK Investigational Site, Fayetteville

15801

GSK Investigational Site, DuBois

20745

GSK Investigational Site, Oxon Hill

28054

GSK Investigational Site, Gastonia

29303

GSK Investigational Site, Spartanburg

29340

GSK Investigational Site, Gaffney

29621

GSK Investigational Site, Anderson

29650

GSK Investigational Site, Greer

29669

GSK Investigational Site, Pelzer

29678

GSK Investigational Site, Seneca

32117

GSK Investigational Site, Daytona Beach

32174

GSK Investigational Site, Ormond Beach

32405

GSK Investigational Site, Panama City

32825

GSK Investigational Site, Orlando

33014

GSK Investigational Site, Miami Lakes

33126

GSK Investigational Site, Miami

33134

GSK Investigational Site, Miami

34741

GSK Investigational Site, Kissimmee

36420

GSK Investigational Site, Andalusia

43016

GSK Investigational Site, Dublin

45242

GSK Investigational Site, Cincinnati

55407

GSK Investigational Site, Minneapolis

55435

GSK Investigational Site, Edina

75110

GSK Investigational Site, Corsicana

77340

GSK Investigational Site, Huntsville

80907

GSK Investigational Site, Colorado Springs

83687

GSK Investigational Site, Nampa

84102

GSK Investigational Site, Salt Lake City

92647

GSK Investigational Site, Huntington Beach

93065

GSK Investigational Site, Simi Valley

95821

GSK Investigational Site, Sacramento

111539

GSK Investigational Site, Moscow

115682

GSK Investigational Site, Moscow

153005

GSK Investigational Site, Ivanovo

196084

GSK Investigational Site, Saint Petersburg

197022

GSK Investigational Site, Saint Petersburg

198260

GSK Investigational Site, Saint Petersburg

199106

GSK Investigational Site, Saint Petersburg

394066

GSK Investigational Site, Voronezh

410028

GSK Investigational Site, Saratov

432063

GSK Investigational Site, Ulyanovsk

620109

GSK Investigational Site, Yekaterinburg

630008

GSK Investigational Site, Novosibirsk

630087

GSK Investigational Site, Novosibirsk

029566

GSK Investigational Site, Little River

15-003

GSK Investigational Site, Bialystok

15-044

GSK Investigational Site, Bialystok

43-300

GSK Investigational Site, Bielsko-Biala

85-796

GSK Investigational Site, Bydgoszcz

85-863

GSK Investigational Site, Bydgoszcz

89-600

GSK Investigational Site, Chojnice

86-300

GSK Investigational Site, Grudziądz

25-751

GSK Investigational Site, Kielce

30-033

GSK Investigational Site, Krakow

31-209

GSK Investigational Site, Krakow

20-412

GSK Investigational Site, Lublin

67-100

GSK Investigational Site, Nowa Sól

27-400

GSK Investigational Site, Ostrowiec Świętokrzyski

14-100

GSK Investigational Site, Ostróda

05-500

GSK Investigational Site, Piaseczno

32-100

GSK Investigational Site, Proszowice

08-110

GSK Investigational Site, Siedlce

96-100

GSK Investigational Site, Skierniewice

81-741

GSK Investigational Site, Sopot

58-100

GSK Investigational Site, Swidnica

71-124

GSK Investigational Site, Szczecin

87-100

GSK Investigational Site, Torun

02-777

GSK Investigational Site, Warsaw

22-400

GSK Investigational Site, Zamość

47-120

GSK Investigational Site, Zawadzkie

115 280

GSK Investigational Site, Moscow