Overview

Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo

Status:
Completed
Trial end date:
2016-03-17
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
Collaborator:
Novartis
Treatments:
Ciprofloxacin
Criteria
Inclusion Criteria

- Subjects (male and female) with non-cystic fibrosis bronchiectasis (NCFB) or chronic
obstructive pulmonary disease (COPD)

- Subjects must be aged ≥40

- Subject must be able to independently manage and administer their NCFB/COPD
medications

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