Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
Clinical Study of the Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients Responding to Inhaled Corticosteroid (ICS) Treatment
1 other identifier
interventional
122
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable asthma
Started Sep 2020
Shorter than P25 for not_applicable asthma
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2020
CompletedFirst Posted
Study publicly available on registry
June 29, 2020
CompletedStudy Start
First participant enrolled
September 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 13, 2021
CompletedResults Posted
Study results publicly available
June 6, 2022
CompletedJune 6, 2022
May 1, 2022
3 months
June 24, 2020
April 12, 2022
May 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change in FeNO Value
Change in FeNO value before and after inhaled corticosteroid treatment
14 days
Study Arms (1)
Test Cohort
EXPERIMENTALSubjects age 7 to 80 with asthma
Interventions
Breath gas analysis
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bosch Healthcare Solutions GmbHlead
- Global BioClinicalcollaborator
Study Sites (6)
Clinical Research Center of Alabama
Birmingham, Alabama, 35209, United States
Kern Research, Inc.
Bakersfield, California, 93301, United States
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, 21162, United States
The Clinical Research Center, LLC
St Louis, Missouri, 63141, United States
North Carolina Clinical Research
Raleigh, North Carolina, 27607, United States
Allergy Asthma Research Institute
Waco, Texas, 76712, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Klaus Müller, Study director
- Organization
- Bosch Healthcare Solutions
Study Officials
- STUDY DIRECTOR
Klaus Mueller
Bosch Healthcare
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2020
First Posted
June 29, 2020
Study Start
September 8, 2020
Primary Completion
December 18, 2020
Study Completion
April 13, 2021
Last Updated
June 6, 2022
Results First Posted
June 6, 2022
Record last verified: 2022-05