Asthma Clinical Trial
Official title:
204980: An Open-label Study to Evaluate the Correct Use of Placebo ELLIPTA™ Dry Powder Inhaler (DPI) Compared to Placebo Metered Dose Inhalers (MDI) in Subjects With Moderate Persistent Asthma
The study is conducted to evaluate the potentially improved patient handling of the ELLIPTA
Dry Powder Inhaler (DPI). Therefore, the study aims to evaluate errors encountered by subject
with asthma during handling ELLIPTA DPI relative to two metered dose inhalers (MDI), a GSK
MDI and the AstraZeneca (AZ) MDI. It is a randomised, multi-centre, open-label, cross-over
study comparing placebo ELLIPTA DPI with placebo MDI (GSK and AZ) to assess correct inhaler
use. No active drug will be used in this study in order to prevent any drug-related effects.
Approximately, 152 subjects will be randomized to receive ELLIPTA DPI inhaler and 152 will be
randomized to receive one of the MDI inhalers, for use during the first period (P)
(approximately 28 days). At Visit 2 (Day 28) all subjects previous receiving the ELLIPTA DPI
will be randomized to receive one of the MDI inhalers and all subjects who received a MDI in
the previous period will receive the ELLIPTA DPI for use during second period (approximately
28 days). Subjects will continue taking their asthma maintenance treatment and limited rescue
albuterol MDI during the entire 56-day study period.
ELLIPTA is a registered trademark of the GSK group of companies.
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