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)

GlaxoSmithKline

Description

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.

Citations (0)

Mentions (0)

Metrics

Dataset Index

0.2

FAIR Score

31%

Citations

0

Mentions

0

Metrics Over Time

Publication Details

DOI

Publisher

Vivli

License

Study data may be accessed by completing a request form at https://vivli.org. It will then be reviewed according to the data contributor’s governance policy, see https://vivli.org/members/ourmembers/ for Vivli member’s review process. If approved, use of the data is governed by the data use agreement at https://vivli.org/resources/vivli-data-use-agreement/

Assigned Domain

Subfield

Pulmonary and Respiratory Medicine

Field

Medicine

Domain

Health Sciences

Confidence Score

54%

Source

Scholar Data Model

Keywords

Conditions: Pulmonary Disease, Chronic ObstructiveInterventions: Placebo ELLIPTA deviceInterventions: Placebo capsules for use in HANDIHALER deviceInterventions: Inhaler Preference Questionnaire Version 1Interventions: Inhaler Preference Questionnaire Version 2

Normalization Factors

FT

59.62

CTw

1.00

MTw

1.00