Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo

Not Applicable

Completed

• Conditions: Bronchiectasis; Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Placebo to Ciprofloxacin DPI (BAYQ3939)

• Registration Number: NCT02661438
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-30
• Study Start: 2016-01-12
• Study First Submitted QC: 2016-01-19
• Study First Posted: 2016-01-22
• Primary Completion: 2016-03-17
• Study Completion: 2016-03-17
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-17
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo to Ciprofloxacin DPI	Placebo to Ciprofloxacin DPI (BAYQ3939)	Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
User friendliness	1 Day	User friendliness is assessd by a questionnaire.
Inhalation time	1 Day	Inhalation time is assessed with a stop watch.