check_circleStudy Completed
Bronchiectasis, Pulmonary Disease, Chronic Obstructive
Bayer Identifier:
18253
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
40 - N/ATrial summary
Enrollment Goal
46Trial Dates
January 2016 - March 2016Phase
N/ACould I Receive a placebo
YesProducts
UnspecifiedAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Vero Beach, 32960, United States | |
Completed | Jamaica, 11435, United States |
Primary Outcome
- The user performed the inhalation task based on the given instructions properly (Yes/No).The performance was assessed by a test administrator.date_rangeTime Frame:1 Dayenhanced_encryptionNoSafety Issue:
- The user performed the inhalation task safely (Yes/No).The user safety was assessed by a test administrator.date_rangeTime Frame:1 Dayenhanced_encryptionYesSafety Issue:
- DPI (Dry powder for inhalation) device malfunction (Yes/No).The function was assessed by a test administrator.date_rangeTime Frame:1 Dayenhanced_encryptionNoSafety Issue:
- Subject's subjective feedback (paraphrased) on use-safety and usabilitydate_rangeTime Frame:1 Dayenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Inhalation timeInhalation time is assessed with a stop watch.date_rangeTime Frame:1 Dayenhanced_encryptionNoSafety Issue:
- User friendlinessUser friendliness is assessd by a questionnaire.date_rangeTime Frame:1 Dayenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1