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DISKUS vs. ELLIPTA Device Preference Study in Chronic Obstructive Pulmonary Disease (COPD)

GlaxoSmithKline · 2013
ClinicalTrials.gov · Datasets · License: Public Domain · 2013
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chronic-obstructivecopdpulmonary-disease
Subjects who have not used the ELLIPTA™ inhaler nor the DISKUS™ inhaler in the past 6 months will be screened to participate in the study. Subjects will have an equal chance of being in any of the following two groups (1:1 allocation). One group will be dispensed the ELLIPTA inhaler at Visit 1 to use during the first period (once daily for 5 to9 days), and the DISKUS inhaler at Visit 2 to use during the second period (twice daily for 5 to 9 days). The other group will be dispensed the DISKUS inhaler at Visit 1 to use during the first period (twice daily for 5 to 9 days), and the ELLIPTA inhaler at Visit 2 to use during the second period (once daily for 5 to9 days). At the end of the second period, subjects will complete the study by answering 7 questions to assess their preference of device attributes and dosing regimens between the two inhalers. The null hypothesis for device preference for a specific attribute is that 50% subjects express a preference in that attribute for ELLIPTA and 50% do NOT express a preference in that attribute for ELLIPTA, i.e., the odds for preferring ELLIPTA to not preferring ELLIPTA is unity. The null hypothesis for dosing regimen preference is that 50% subjects express a preference of once daily dosing and 50% do not express a preference of once daily dosing (prefer twice daily dosing or have no preference).
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