Asthma Clinical Trial
Official title:
An Open-label Study of Inhaler Device Attributes Investigating Critical and Overall Errors, and Ease of Use and Preference Between a Number of Inhaler Devices (ELLIPTA, DISKUS/ACCUHALER, TURBUHALER, and MDI) in Adult Subjects With Asthma (Study 200330)
This study is designed to assess the proportion of asthma subjects making critical and
non-critical errors made in using ELLIPTA® inhaler compared with other commercially available
inhaler devices such as the TURBUHALER®, MDI (metered-dose inhaler), and DISKUS/ACCUHALER®.
This study will also assess the ease of use and preference between the ELLIPTA inhaler and
the other commercially available inhaler devices. This is a randomized, open-label, placebo,
crossover, multicentre study with a single visit. The study will comprise three 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 allocated to. Only subjects who are
naïve to the ELLIPTA inhaler and to one of the other inhalers that will be used in this study
will be included. The study will be conducted in the Netherlands and the UK, and comprises
one visit only. A sufficient number of subjects (at least 190) with asthma will be screened
and 180 will be randomized to one of the three sub-studies. Eligible subjects will be
allocated to one of the sub-studies in the following order depending on their experience of
using the other inhaler (i.e., depending on which other inhaler they are naïve to).
ELLIPTA, DISKUS, and ACCUHALER are registered trademarks of the GSK group of companies.
TURBUHALER is a registered trademark of AstraZeneca.
This is a non-interventional study and not an observational study and therefore some fields are not applicable for the CT.gov observational study design. It would be preferential to have the field populated as "not applicable" for sampling method, time perspective, and observational study model as they don't apply to this study design. ;
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