The rationale of this study is to conduct a summative (i.e., validation) usability test of Ciprofloxacin Dry Powder for Inhalation (DPI) and the associated Instructions for Use.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
46
Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training
Unnamed facility
Vero Beach, Florida, United States
Unnamed facility
Jamaica, New York, United States
The user performed the inhalation task based on the given instructions properly (Yes/No).
The performance was assessed by a test administrator.
Time frame: 1 Day
The user performed the inhalation task safely (Yes/No).
The user safety was assessed by a test administrator.
Time frame: 1 Day
DPI (Dry powder for inhalation) device malfunction (Yes/No).
The function was assessed by a test administrator.
Time frame: 1 Day
Subject's subjective feedback (paraphrased) on use-safety and usability
Time frame: 1 Day
Inhalation time
Inhalation time is assessed with a stop watch.
Time frame: 1 Day
User friendliness
User friendliness is assessd by a questionnaire.
Time frame: 1 Day
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