Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo

NCT ID: NCT02661438

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-12

Study Completion Date

2016-03-17

Brief Summary

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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.

Detailed Description

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Conditions

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Bronchiectasis Pulmonary Disease, Chronic Obstructive

Keywords

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Usability Test

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Placebo to Ciprofloxacin DPI

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

Group Type OTHER

Placebo to Ciprofloxacin DPI (BAYQ3939)

Intervention Type DRUG

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

Interventions

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Placebo to Ciprofloxacin DPI (BAYQ3939)

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Vero Beach, Florida, United States

Site Status

Jamaica, New York, United States

Site Status

Countries

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United States

Other Identifiers

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18253

Identifier Type: -

Identifier Source: org_study_id