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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo to Ciprofloxacin DPI | Other | Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo to Ciprofloxacin DPI (BAYQ3939) | Drug | Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Inhalation time | Inhalation time is assessed with a stop watch. | 1 Day |
| User friendliness | User friendliness is assessd by a questionnaire. |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vero Beach | Florida | 32960 | United States | |||
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| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 1 Day |
| Jamaica |
| New York |
| 11435 |
| United States |
| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |