Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo

Bayer

Status: Completed

Conditions: Bronchiectasis; Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Placebo to Ciprofloxacin DPI (BAYQ3939)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02661438

18253

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Placebo to Ciprofloxacin DPI

Other group

Description:

Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training

Treatment:

Drug: Placebo to Ciprofloxacin DPI (BAYQ3939)