Background: Wixela Inhub is a generic version of
Advair Diskus recently approved by the U.S. Food and Drug Administration. The Inhub
inhaler delivers
fluticasone propionate (FP)/
salmeterol in a dry
powder formulation. The goals of our studies were to demonstrate that the Inhub
inhaler can be used by representative end users and confirm the robustness of the Inhub
inhaler. Methods: Study 1: A nondosing usability assessment, the device orientation study, confirmed that intended users (represented by patients diagnosed with
asthma or
chronic obstructive pulmonary disease [
COPD] who were naive to
dry powder inhalers and current
Advair Diskus users) could use the Inhub
inhaler safely and effectively. Subjects were provided with an Inhub
inhaler in commercial packaging, including instructions for use, and were asked to undertake three dose simulations using the
inhaler. Subjects were encouraged to interact with this new
drug delivery device as they would at home. Subjects were not provided with training on the use of the device. Subjects were observed interacting with the Inhub
inhaler, and those who currently use Diskus were also observed interacting with the Diskus to determine whether their mental model of the use of Diskus impacted their interaction with the Inhub device, this assessment was not a primary outcome of the study. Study 2: This is an open-label clinical study to confirm the robustness of the Inhub
inhaler after at home patient use. Subjects diagnosed with
asthma or
COPD were provided Inhub
inhaler training and subsequently self-administered 3 weeks of twice daily doses of Wixela Inhub 250 μg FP/50 μg
salmeterol in the home environment. The Inhub
inhalers were returned to the investigator after ∼3 weeks of outpatient use for in vitro tests on the
drug remaining in each
inhaler. Results: Study 1 enrolled 110 subjects, and all completed the study. Most subjects (100/110) held the Inhub
inhaler in the correct orientation and of those who did not, 9 still achieved a peak inhalation flow rate of ≥30 L/min and a total inhaled volume of ≥1 L, thus meeting the requirements of the study success criteria. In Study 2, 111 pediatric, adult, and elderly subjects with
asthma or
COPD received the study
drug. After ∼3 weeks of outpatient use of the Inhub
inhaler by subjects, comprehensive in vitro testing demonstrated that the FP and
salmeterol pharmaceutical performance in the Inhub
inhaler was preserved. Conclusions: The majority of subjects demonstrated safe and effective use of the Inhub
inhaler. In vitro testing and inspections confirmed the robustness of the Inhub
inhaler after outpatient use. Clinical trial registration number: NCT02474017.