Comparative Study of ELLIPTA Dry Powder Inhaler (DPI) Versus DISKUS DPI Used With HandiHaler DPI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

PHASE4CompletedINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

September 20, 2017

Primary Completion Date

January 4, 2018

Study Completion Date

January 4, 2018

Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
DEVICE

ELLIPTA placebo DPI

ELLIPTA is a dry powder inhaler used via oral route. It will be a placebo DPI with two strips with 30 blisters per strip. First strip will contain lactose monohydrate and the second strip will contain lactose monohydrate blended with magnesium stearate.

DEVICE

DISKUS placebo DPI

DISKUS is a dry powder inhaler used via oral route. It will be a placebo DPI with one blister strip that will contain lactose monohydrate.

DEVICE

HandiHaler placebo DPI

HandiHaler is a dry powder inhaler used via oral route. It will be a DPI with placebo capsules that will contain lactose monohydrate.

OTHER

Inhaler preference questionnaires

Preference questionnaires will be given to subjects to understand the inhaler preference. There will be 2 types of questionnaire, preference questionnaires 1 and 2, which will be randomized at visit 3 (Day 56).

Trial Locations (18)

23225

GSK Investigational Site, Richmond

23229

GSK Investigational Site, Richmond

28054

GSK Investigational Site, Gastonia

28112

GSK Investigational Site, Monroe

28117

GSK Investigational Site, Mooresville

28207

GSK Investigational Site, Charlotte

29303

GSK Investigational Site, Spartanburg

29615

GSK Investigational Site, Greenville

29621

GSK Investigational Site, Anderson

29732

GSK Investigational Site, Rock Hill

32825

GSK Investigational Site, Orlando

44718

GSK Investigational Site, Canton

45231

GSK Investigational Site, Cincinnati

45419

GSK Investigational Site, Dayton

63301

GSK Investigational Site, Saint Charles

71457

GSK Investigational Site, Natchitoches

73120

GSK Investigational Site, Oklahoma City

97504

GSK Investigational Site, Medford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY