Dose-Finding Study of Batefenterol (GSK961081) Via Dry Powder Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)

PHASE2CompletedINTERVENTIONAL
Enrollment

325

Participants

Timeline

Start Date

November 6, 2015

Primary Completion Date

July 6, 2016

Study Completion Date

July 6, 2016

Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
DRUG

Batefenterol

Batefenterol will be provided as dry white powder for inhalation via a DPI with 30 doses (2 strips with 30 blisters per strip). First strip will contain lactose and the second strip will contain batefenterol blended with lactose with a unit dose strength of 37.5 mcg, 75 mcg, 150 mcg, 300 mcg, or 600 mcg per blister

DRUG

Umeclidinium/ Vilanterol

Umeclidinium/Vilanterol will be provided as dry white powder for inhalation via a DPI with 30 doses (2 strips with 30 blisters per strip). First strip will contain umeclidinium blended with lactose and magnesium stearate with a unit dose strength of 62.5 mcg per blister and the second strip will contain vilanterol blended with lactose and magnesium stearate with a unit dose strength of 25 mcg per blister

DRUG

Placebo

Placebo will be provided as dry white powder for inhalation via a DPI with 30 doses (2 strips with 30 blisters per strip) containing lactose

Trial Locations (25)

184

GSK Investigational Site, Meyerspark/ Pretoria

1050

GSK Investigational Site, Middelburg

6001

GSK Investigational Site, Port Elizabeth

7130

GSK Investigational Site, Somerset West

7530

GSK Investigational Site, Bellville

7700

GSK Investigational Site, Mowbray

9301

GSK Investigational Site, Bloemfontein

10119

GSK Investigational Site, Berlin

10717

GSK Investigational Site, Berlin

10787

GSK Investigational Site, Berlin

15562

GSK Investigational Site, Rüdersdorf

21225

GSK Investigational Site, Baltimore

22299

GSK Investigational Site, Hamburg

22927

GSK Investigational Site, Großhansdorf

23552

GSK Investigational Site, Lübeck

29303

GSK Investigational Site, Spartanburg

29379

GSK Investigational Site, Union

29615

GSK Investigational Site, Greenville

29621

GSK Investigational Site, Anderson

29681

GSK Investigational Site, Simpsonville

33013

GSK Investigational Site, Hialeah

65187

GSK Investigational Site, Wiesbaden

97504

GSK Investigational Site, Medford

63141-6361

GSK Investigational Site, St Louis

Unknown

GSK Investigational Site, Thabazimbi

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY