Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
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)
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.
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