Preference Attributes of ELLIPTA Dry Powder Inhaler (DPI) and HANDIHALER DPI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

PHASE4CompletedINTERVENTIONAL
Enrollment

214

Participants

Timeline

Start Date

June 21, 2016

Primary Completion Date

October 4, 2016

Study Completion Date

October 4, 2016

Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
DRUG

Placebo ELLIPTA device

Placebo ELLIPTA is a DPI device containing powder for inhalation, to be inhaled orally once daily for 5-9 days. It contains two strips with 30 blisters per strip - one strip contains lactose monohydrate whereas the other strip contains lactose monohydrate blended with magnesium stearate.

DRUG

Placebo capsules for use in HANDIHALER device

Placebo capsules contain lactose monohydrate in the form of powder for inhalation, to be used with the HANDIHALER inhaler as an oral inhalation once daily for 5-9 days.

OTHER

Inhaler Preference Questionnaire Version 1

Consists of 5 questions to assess subjects' preference of device attributes and dosing regimens. The two versions of the questionnaire ask the same questions, but differ in the ordering of inhalers in their responses.

OTHER

Inhaler Preference Questionnaire Version 2

Consists of 5 questions to assess subjects' preference of device attributes and dosing regimens. The two versions of the questionnaire ask the same questions, but differ in the ordering of inhalers in their responses.

Trial Locations (22)

21237

GSK Investigational Site, Baltimore

23225

GSK Investigational Site, Richmond

29303

GSK Investigational Site, Spartanburg

29341

GSK Investigational Site, Gaffney

29379

GSK Investigational Site, Union

29615

GSK Investigational Site, Greenville

29621

GSK Investigational Site, Anderson

29640

GSK Investigational Site, Easley

29732

GSK Investigational Site, Rock Hill

32825

GSK Investigational Site, Orlando

33603

GSK Investigational Site, Tampa

33765

GSK Investigational Site, Clearwater

43213

GSK Investigational Site, Columbus

45231

GSK Investigational Site, Cincinnati

45419

GSK Investigational Site, Dayton

55402

GSK Investigational Site, Minneapolis

55441

GSK Investigational Site, Plymouth

70584

GSK Investigational Site, Sunset

71457

GSK Investigational Site, Natchitoches

76542

GSK Investigational Site, Killeen

85306

GSK Investigational Site, Glendale

29406-7108

GSK Investigational Site, Charleston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02786927 - Preference Attributes of ELLIPTA Dry Powder Inhaler (DPI) and HANDIHALER DPI in Subjects With Chronic Obstructive Pulmonary Disease (COPD) | Biotech Hunter | Biotech Hunter