Trials Sponsors Conditions Drugs Pricing

Conditions

Bronchiectasis Pulmonary Disease, Chronic Obstructive

Keywords

Usability Test

Outcome Measures

Primary Outcomes (4)

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

Secondary Outcomes (2)

Inhalation time
1 Day
User friendliness
1 Day

Study Arms (1)

Placebo to Ciprofloxacin DPI

OTHER

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

Drug: Placebo to Ciprofloxacin DPI (BAYQ3939)

Interventions

Placebo to Ciprofloxacin DPI (BAYQ3939)Drug

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

Placebo to Ciprofloxacin DPI

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects (male and female) with non-cystic fibrosis bronchiectasis (NCFB) or chronic obstructive pulmonary disease (COPD)
Subjects must be aged ≥40

Sponsors & Collaborators

Novartis
Industrycollaborator
Bayer
Industrylead

Study Sites (2)

Vero Beach, Florida, 32960, United States

Jamaica, New York, 11435, United States

MeSH Terms

Conditions

BronchiectasisPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Bayer Study Director
Bayer
STUDY DIRECTOR

Enrollment

46 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: OTHER
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 30, 2015

First Posted

January 22, 2016

Study Start

January 12, 2016

Actual (reported)

Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (2)

Study Arms (1)

Placebo to Ciprofloxacin DPI

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (2)

Study Arms (1)

Placebo to Ciprofloxacin DPI

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations