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An Open-label Study to Evaluate the Preference Attributes of the ELLIPTA™ Dry Powder Inhaler (DPI) Compared to the HandiHaler™ DPI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
This is a Phase IV multi-center, randomized, open-label, cross-over, placebo study in subjects with Chronic Obstructive Pulmonary Disease (COPD) to compare inhaler-specific preference attributes of two inhalers - ELLIPTA dry powder inhaler (DPI) and the HANDIHALER DPI. The primary objective of this study is to evaluate whether more subjects with COPD prefer the ELLIPTA inhaler to the HANDIHALER DPI based on the number of steps needed to take medication. All subjects will use the ELLIPTA inhaler and the HANDIHALER inhaler in the corresponding treatment periods based on the randomisation scheme, and at the end of 2 periods, complete the inhaler preference questionnaire. Subjects will self-administer the inhalation once daily for 5-9 days in each treatment period. This study will be placebo-only, and neither inhaler will contain active treatment. Subjects will continue their current COPD medication(s) as prescribed, and will follow up with their regular physician for their COPD healthcare during the study. Approximately 211 subjects will be enrolled in the study. ELLIPTA is a trademark of the GlaxoSmithKline group of companies. HANDIHALER is a trademark of Boehringer Ingelheim International GmbH.
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
No
GSK Investigational Site
Glendale, Arizona, United States
GSK Investigational Site
Clearwater, Florida, United States
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Natchitoches, Louisiana, United States
GSK Investigational Site
Sunset, Louisiana, United States
GSK Investigational Site
Baltimore, Maryland, United States
GSK Investigational Site
Minneapolis, Minnesota, United States
GSK Investigational Site
Plymouth, Minnesota, United States
GSK Investigational Site
Cincinnati, Ohio, United States
Start Date
June 21, 2016
Primary Completion Date
October 4, 2016
Completion Date
October 4, 2016
Last Updated
October 15, 2018
214
ACTUAL participants
Placebo ELLIPTA device
DRUG
Placebo capsules for use in HANDIHALER device
DRUG
Inhaler Preference Questionnaire Version 1
OTHER
Inhaler Preference Questionnaire Version 2
OTHER
Lead Sponsor
GlaxoSmithKline
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05050591