Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
RLV116669, A Preference Study of Device Attributes Between Two Placebo Dry Powder Inhalers; ELLIPTA and DISKUS, in Adult Subjects With Chronic Obstructive Pulmonary 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).
n/a
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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