Back to resultsSummative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo
Primary Purpose
Bronchiectasis, Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo to Ciprofloxacin DPI (BAYQ3939)
Sponsored by
About this trial
This is an interventional other trial for Bronchiectasis focused on measuring Usability Test
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Placebo to Ciprofloxacin DPI
Arm Description
Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training
Outcomes
Primary Outcome Measures
The user performed the inhalation task based on the given instructions properly (Yes/No).
The performance was assessed by a test administrator.
The user performed the inhalation task safely (Yes/No).
The user safety was assessed by a test administrator.
DPI (Dry powder for inhalation) device malfunction (Yes/No).
The function was assessed by a test administrator.
Subject's subjective feedback (paraphrased) on use-safety and usability
Secondary Outcome Measures
Inhalation time
Inhalation time is assessed with a stop watch.
User friendliness
User friendliness is assessd by a questionnaire.
Full Information
NCT ID
NCT02661438
First Posted
December 30, 2015
Last Updated
December 17, 2018
Sponsor
Bayer
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT02661438
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 12, 2016 (Actual)
Primary Completion Date
March 17, 2016 (Actual)
Study Completion Date
March 17, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Novartis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis, Pulmonary Disease, Chronic Obstructive
Keywords
Usability Test
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo to Ciprofloxacin DPI
Arm Type
Other
Arm Description
Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training
Intervention Type
Drug
Intervention Name(s)
Placebo to Ciprofloxacin DPI (BAYQ3939)
Intervention Description
Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training
Primary Outcome Measure Information:
Title
The user performed the inhalation task based on the given instructions properly (Yes/No).
Description
The performance was assessed by a test administrator.
Time Frame
1 Day
Title
The user performed the inhalation task safely (Yes/No).
Description
The user safety was assessed by a test administrator.
Time Frame
1 Day
Title
DPI (Dry powder for inhalation) device malfunction (Yes/No).
Description
The function was assessed by a test administrator.
Time Frame
1 Day
Title
Subject's subjective feedback (paraphrased) on use-safety and usability
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
Inhalation time
Description
Inhalation time is assessed with a stop watch.
Time Frame
1 Day
Title
User friendliness
Description
User friendliness is assessd by a questionnaire.
Time Frame
1 Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
City
Jamaica
State/Province
New York
ZIP/Postal Code
11435
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo
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