Bronchiectasis, Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Usability Test
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.
Interventions
DRUGPlacebo to Ciprofloxacin DPI (BAYQ3939)
Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training
Sponsors
Novartis
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The user performed the inhalation task based on the given instructions properly (Yes/No). | 1 Day | The performance was assessed by a test administrator. |
| The user performed the inhalation task safely (Yes/No). | 1 Day | The user safety was assessed by a test administrator. |
| DPI (Dry powder for inhalation) device malfunction (Yes/No). | 1 Day | The function was assessed by a test administrator. |
| Subject's subjective feedback (paraphrased) on use-safety and usability | 1 Day | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inhalation time | 1 Day | Inhalation time is assessed with a stop watch. |
| User friendliness | 1 Day | User friendliness is assessd by a questionnaire. |
Countries
United States
Outcome results
None listed