Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo
| Status: | Completed |
|---|---|
| Conditions: | Bronchitis, Chronic Obstructive Pulmonary Disease, Pulmonary, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 12/20/2018 |
| Start Date: | January 12, 2016 |
| End Date: | March 17, 2016 |
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
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.
Ciprofloxacin Dry Powder for Inhalation (DPI) and the associated Instructions for Use.
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
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