NCT02522299 - A Study to Evaluate the Safety, Efficacy and Changes in Induced Sputum and Blood Biomarkers Following Daily Repeat Doses of Inhaled GSK2269557 in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Acute Exacerbation | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 4, 2015

Primary Completion Date

June 15, 2018

Study Completion Date

June 22, 2018

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

GSK2269557

GSK2269557 500 mcg blended with lactose per blister and will be administered using a DISKUS dry powder inhaler device. Since GSK2269557 will no longer be manufactured for use with the DISKUS device, it will be replaced with ELLIPTA Device. Subjects will receive GSK2269557 700 mcg once daily for 84 consecutive days via ELLIPTA.

DRUG

Placebo

Lactose will be administered using a DISKUS and ELLIPTA dry powder inhaler device

DEVICE

DISKUS

It is multi-dose dry powder inhaler containing one foil strip of drug with 60 blisters

DEVICE

ELLIPTA

It is multi-dose dry powder inhaler containing one foil strip of drug with 30 blisters

Trial Locations (6)

V5Z 1M9

GSK Investigational Site, Vancouver

L8N 3Z5

GSK Investigational Site, Hamilton

H4A 3J1

GSK Investigational Site, Montreal

H2W1T8

GSK Investigational Site, Montreal

G1V 4G5

GSK Investigational Site, Québec

DK-5000

GSK Investigational Site, Odense