Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo
Not Applicable
Completed
- Conditions
- BronchiectasisPulmonary Disease, Chronic Obstructive
- Interventions
- Registration Number
- NCT02661438
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
Inclusion Criteria
Not provided
Exclusion Criteria
- Subjects with recent exacerbation
- Subjects with recent significant hemoptysis in the four weeks before screening (and/or during the screening period)
- Subjects allergic to quinine
- Known chronic bronchial asthma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo to Ciprofloxacin DPI Placebo to Ciprofloxacin DPI (BAYQ3939) Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training
- Primary Outcome Measures
Name Time Method The user performed the inhalation task safely (Yes/No). 1 Day The user safety was assessed by a test administrator.
DPI (Dry powder for inhalation) device malfunction (Yes/No). 1 Day The function was assessed by a test administrator.
The user performed the inhalation task based on the given instructions properly (Yes/No). 1 Day The performance was assessed by a test administrator.
Subject's subjective feedback (paraphrased) on use-safety and usability 1 Day
- Secondary Outcome Measures
Name Time Method Inhalation time 1 Day Inhalation time is assessed with a stop watch.
User friendliness 1 Day User friendliness is assessd by a questionnaire.