Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
An Open-label Study of Inhaler Device Attributes Investigating Critical and Overall Errors, Ease of Use, and Preference Between a Number of Inhaler Devices (ELLIPTA, TURBUHALER, HANDIHALER, BREEZHALER, MDI, and DISKUS/ACCUHALER) in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD)
This is a randomised, open-label, placebo, crossover, multicentre study with a single visit.
The study will comprise five sub-studies. Subjects will receive inactive treatment (placebo)
via the ELLIPTA® inhaler and one of the other inhaler devices depending on the sub-study
they are randomised to. Only subjects who are naïve to the ELLIPTA inhaler and to one of the
other inhaler devices that will be used in this study will be included. Furthermore,
subjects who are naïve to the BREEZEHALER® and HANDIHALER® inhalers must be naïve to all
other inhaler devices that requires a capsule. The study will be conducted in the UK and the
Netherlands, and comprises one visit only. A sufficient number of subjects (at least 600)
with COPD will be screened and 570 will be randomised to one of five sub-studies. Eligible
subjects will be allocated to one of the sub-studies depending on their experience of using
the other inhaler (i.e., depending on which other inhaler they are naïve to).
This study is designed to assess the proportion of COPD subjects making critical and overall
(i.e., critical and non-critical errors) errors in using ELLIPTA inhaler and other
commercially available inhaler devices such as the TURBUHALER®, HANDIHALER, BREEZHALER, MDI
and DISKUS®/ACCUHALER® inhalers. This study will also assess the 'ease of use' and
preference between the ELLIPTA inhaler and the other commercially available inhaler devices.
ELLIPTA, DISKUS, and ACCUHALER are registered trademarks of the GSK group of companies.
TURBUHALER is a registered trademark of AstraZeneca. HANDIHALER is a registered trademark of
Boehringer Ingelheim Pharma GmbH & Co. KG. BREEZHALER is a registered trademark of Novartis
AG.
n/a
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
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