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Completed

NCT Number: NCT02661438

Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using 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.

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Key information

Conditions

Bronchiectasis Bronchial Diseases Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vero Beach, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo to Ciprofloxacin DPI (BAYQ3939)

Drug

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

Primary outcomes

  1. 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.

  2. The user performed the inhalation task safely (Yes/No).

    Time frame: 1 Day

    The user safety was assessed by a test administrator.

  3. DPI (Dry powder for inhalation) device malfunction (Yes/No).

    Time frame: 1 Day

    The function was assessed by a test administrator.

  4. Subject's subjective feedback (paraphrased) on use-safety and usability

    Time frame: 1 Day

Secondary outcomes

  1. Inhalation time

    Time frame: 1 Day

    Inhalation time is assessed with a stop watch.

  2. User friendliness

    Time frame: 1 Day

    User friendliness is assessd by a questionnaire.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Novartis

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 22, 2016
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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