check_circleStudy Completed

Bronchiectasis, Pulmonary Disease, Chronic Obstructive

Bayer Identifier:

18253

ClinicalTrials.gov Identifier:

NCT02661438

EudraCT Number:

Not Available

EU CT Number:

Not Available
Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

40 - N/A
  • - 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
  • - 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 summary

Enrollment Goal
46
Trial Dates
January 2016 - March 2016
Phase
N/A
Could I Receive a placebo
Yes
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Vero Beach, 32960, United States
Completed
Jamaica, 11435, United States

Primary Outcome

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

Secondary Outcome

  • Inhalation time
    Inhalation time is assessed with a stop watch.
    date_rangeTime Frame:
    1 Day
    enhanced_encryption
    Safety Issue:
    No
  • User friendliness
    User friendliness is assessd by a questionnaire.
    date_rangeTime Frame:
    1 Day
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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