Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo
NCT02661438 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2018-12-19
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.
Conditions
- Bronchiectasis
- Pulmonary Disease, Chronic Obstructive
Interventions
- DRUG
-
Placebo to Ciprofloxacin DPI (BAYQ3939)
Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training
Sponsors & Collaborators
Principal Investigators
-
Bayer Study Director · Bayer
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-12
- Primary Completion
- 2016-03-17
- Completion
- 2016-03-17
- FDA Drug
- Yes
Countries
- United States
Study Locations
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