Brief Title
Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo
Official Title
Multicenter Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation in Subjects With Non-Cystic Fibrosis Bronchiectasis (NCFB) or Chronic Obstructive Pulmonary Disease (COPD) Using Matching Placebo
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.
Study Type
Interventional
Primary Outcome
The user performed the inhalation task based on the given instructions properly (Yes/No).
Secondary Outcome
Inhalation time
Condition
Bronchiectasis
Intervention
Placebo to Ciprofloxacin DPI (BAYQ3939)
Study Arms / Comparison Groups
Placebo to Ciprofloxacin DPI
Description: Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
46
Start Date
January 12, 2016
Completion Date
March 17, 2016
Primary Completion Date
March 17, 2016
Eligibility 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
Gender
All
Ages
40 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Bayer Study Director, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02661438
Organization ID
18253
Responsible Party
Sponsor
Study Sponsor
Bayer
Collaborators
Novartis
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
December 2018