Status:
COMPLETED
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
Lead Sponsor:
Bosch Healthcare Solutions GmbH
Collaborating Sponsors:
Global BioClinical
Conditions:
Asthma
Asthma in Children
Eligibility:
All Genders
7-80 years
Phase:
NA
Brief Summary
This is a multi-center study to evaluate fractional exhaled nitric oxide (FeNO) measured with the Vivatmo pro in adult and pediatric subjects.
Detailed Description
Subjects will be screened, enrolled and tested at Study Visit #1 and then prescribed inhaled corticosteroid (ICS) treatment as per routine clinical care. Subjects will return for Study Visit #2 in two...
Eligibility Criteria
Inclusion
- Subject is 7 to 80 years of age.
- Has asthma
- Has been identified as a candidate for inhaled corticosteroid (ICS) treatment
- Is willing and able to perform Vivatmo pro™ testing
Exclusion
- Subject has used corticosteroids prior to enrollment.
- Subject has other current serious medical conditions
- Subject has not been clinically stable for at least 2 weeks prior to the study
- Subject is unwilling or unable to perform Vivatmo pro testing
Key Trial Info
Start Date :
September 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2021
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT04450108
Start Date
September 8 2020
End Date
April 13 2021
Last Update
June 6 2022
Active Locations (6)
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1
Clinical Research Center of Alabama
Birmingham, Alabama, United States, 35209
2
Kern Research, Inc.
Bakersfield, California, United States, 93301
3
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, United States, 21162
4
The Clinical Research Center, LLC
St Louis, Missouri, United States, 63141