Trial Condition(s):
Bronchiectasis, Pulmonary Disease, Chronic Obstructive
Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo
Bayer Identifier:
18253
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
No Inclusion Criteria Available
Exclusion 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 - 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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Vero Beach, United States, 32960 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jamaica, United States, 11435 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- The user performed the inhalation task based on the given instructions properly (Yes/No).The performance was assessed by a test administrator.Timeframe: 1 Day
- The user performed the inhalation task safely (Yes/No).The user safety was assessed by a test administrator.Timeframe: 1 Day
- DPI (Dry powder for inhalation) device malfunction (Yes/No).The function was assessed by a test administrator.Timeframe: 1 Day
- Subject's subjective feedback (paraphrased) on use-safety and usabilityTimeframe: 1 Day
Secondary Outcome
- Inhalation timeInhalation time is assessed with a stop watch.Timeframe: 1 Day
- User friendlinessUser friendliness is assessd by a questionnaire.Timeframe: 1 Day
Additional Information
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