Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo
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
1 other identifier
interventional
46
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2016
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2015
CompletedStudy Start
First participant enrolled
January 12, 2016
CompletedFirst Posted
Study publicly available on registry
January 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2016
CompletedDecember 19, 2018
December 1, 2018
2 months
December 30, 2015
December 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
The user performed the inhalation task based on the given instructions properly (Yes/No).
The performance was assessed by a test administrator.
1 Day
The user performed the inhalation task safely (Yes/No).
The user safety was assessed by a test administrator.
1 Day
DPI (Dry powder for inhalation) device malfunction (Yes/No).
The function was assessed by a test administrator.
1 Day
Subject's subjective feedback (paraphrased) on use-safety and usability
1 Day
Secondary Outcomes (2)
Inhalation time
1 Day
User friendliness
1 Day
Study Arms (1)
Placebo to Ciprofloxacin DPI
OTHERPlacebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training
Interventions
Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Vero Beach, Florida, 32960, United States
Unknown Facility
Jamaica, New York, 11435, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2015
First Posted
January 22, 2016
Study Start
January 12, 2016
Primary Completion
March 17, 2016
Study Completion
March 17, 2016
Last Updated
December 19, 2018
Record last verified: 2018-12