Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02661438
• Other study ID #: 18253
• Status: Completed
• Phase: N/A
• Start date: January 12, 2016
• Est. completion date: March 17, 2016

Study information

• Verified date: December 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 17, 2016
• Est. primary completion date: March 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis
• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Placebo to Ciprofloxacin DPI (BAYQ3939)
Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The user performed the inhalation task based on the given instructions properly (Yes/No).	The performance was assessed by a test administrator.	1 Day
Primary	The user performed the inhalation task safely (Yes/No).	The user safety was assessed by a test administrator.	1 Day
Primary	DPI (Dry powder for inhalation) device malfunction (Yes/No).	The function was assessed by a test administrator.	1 Day
Primary	Subject's subjective feedback (paraphrased) on use-safety and usability		1 Day
Secondary	Inhalation time	Inhalation time is assessed with a stop watch.	1 Day
Secondary	User friendliness	User friendliness is assessd by a questionnaire.	1 Day

External Links

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