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