Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo

December 17, 2018 updated by: Bayer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Vero Beach, Florida, United States, 32960
    • New York
      • Jamaica, New York, United States, 11435

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Placebo to Ciprofloxacin DPI
Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training
Drug: Placebo to Ciprofloxacin DPI (BAYQ3939)
Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The user performed the inhalation task based on the given instructions properly (Yes/No).
Time Frame: 1 Day
The performance was assessed by a test administrator.
1 Day
The user performed the inhalation task safely (Yes/No).
Time Frame: 1 Day
The user safety was assessed by a test administrator.
1 Day
DPI (Dry powder for inhalation) device malfunction (Yes/No).
Time Frame: 1 Day
The function was assessed by a test administrator.
1 Day
Subject's subjective feedback (paraphrased) on use-safety and usability
Time Frame: 1 Day
1 Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inhalation time
Time Frame: 1 Day
Inhalation time is assessed with a stop watch.
1 Day
User friendliness
Time Frame: 1 Day
User friendliness is assessd by a questionnaire.
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2016

Primary Completion (Actual)

March 17, 2016

Study Completion (Actual)

March 17, 2016

Study Registration Dates

First Submitted

December 30, 2015

First Submitted That Met QC Criteria

January 19, 2016

First Posted (Estimate)

January 22, 2016

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 17, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18253

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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