A Study Comparing the Closed Triple Therapy, Open Triple Therapy and a Dual Therapy for Effect on Lung Function in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

June 30, 2016

Primary Completion Date

November 30, 2016

Study Completion Date

November 30, 2016

Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
DRUG

Fluticasone furoate 100 mcg + Umeclidinium 62.5 mcg+Vilanterol 25 mcg

Dry white powder delivered via ELLIPTA inhaler(2 strips with 30 blisters each, first containing fluticasone furoate 100 mcg per blister and second containing Umeclidinium 62.5 mcg and Vilanterol 25 mcg per blister), administered as one inhalation of FF/UMEC/VI (100/62.5/25 mcg) once-daily in the morning

DRUG

Fluticasone furoate 100 mcg + Vilanterol 25 mcg

Dry white powder delivered via ELLIPTA inhaler (2 strips with 30 blisters each, first containing fluticasone furoate 100 mcg per blister and second containing Vilanterol 25 mcg per blister), administered as one inhalation of FF/VI (100/25 mcg) once-daily in the morning

DRUG

Umeclidinium 62.5 mcg

Dry white powder delivered via ELLIPTA inhaler (1 strip with 30 blisters containing Umeclidinium 62.5 mcg, administered as one inhalation once-daily in the morning

DEVICE

Placebo ELLIPTA inhaler

Placebo will be administered via ELLIPTA inhaler. Dry white powder administered as one inhalation each morning (1 strip with 30 blisters containing placebo)

DRUG

Albuterol/Salbutamol

Albuterol/salbutamol will be administered via metered-dose inhaler (MDI) with a spacer as needed throughout the study as a rescue medication

Trial Locations (11)

10119

GSK Investigational Site, Berlin

10717

GSK Investigational Site, Berlin

10787

GSK Investigational Site, Berlin

12159

GSK Investigational Site, Berlin

12203

GSK Investigational Site, Berlin

13156

GSK Investigational Site, Berlin

21502

GSK Investigational Site, Geesthacht

B2N 1L2

GSK Investigational Site, Truro

M3J 2C5

GSK Investigational Site, Toronto

M5G 1N8

GSK Investigational Site, Toronto

J6E 2B4

GSK Investigational Site, Saint-Charles-Borromée

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY