Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo

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Brief Title

Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo

Official Title

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

Brief Summary

      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 Type

Interventional

Primary Outcome

The user performed the inhalation task based on the given instructions properly (Yes/No).

Secondary Outcome

 Inhalation time

Condition

Bronchiectasis

Intervention

Placebo to Ciprofloxacin DPI (BAYQ3939)

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

46

Start Date

January 12, 2016

Completion Date

March 17, 2016

Primary Completion Date

March 17, 2016

Eligibility 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

Gender

All

Ages

40 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Bayer Study Director, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02661438

Organization ID

18253

Responsible Party

Sponsor

Study Sponsor

Bayer

Collaborators

 Novartis

Study Sponsor

Bayer Study Director, Study Director, Bayer

Verification Date

December 2018