Trial Outcomes & Findings for Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients (NCT NCT04450108)
NCT ID: NCT04450108
Last Updated: 2022-06-06
Results Overview
Change in FeNO value before and after inhaled corticosteroid treatment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
122 participants
Primary outcome timeframe
14 days
Results posted on
2022-06-06
Participant Flow
Participant milestones
| Measure |
Test Cohort
Subjects age 7 to 80 with asthma
Vivatmo pro FeNO Test: Breath gas analysis
|
|---|---|
|
Overall Study
STARTED
|
122
|
|
Overall Study
COMPLETED
|
120
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Addition of number adult and children participants covers number of overall participants
Baseline characteristics by cohort
| Measure |
Test Cohort
n=114 Participants
Subjects age 7 to 80 with asthma
Vivatmo pro FeNO Test: Breath gas analysis
|
|---|---|
|
Age, Continuous
|
34.3 years
STANDARD_DEVIATION 16.9 • n=114 Participants
|
|
Age, Customized
Adults
|
41.4 years
STANDARD_DEVIATION 13.6 • n=87 Participants • Addition of number adult and children participants covers number of overall participants
|
|
Age, Customized
Children
|
12.6 years
STANDARD_DEVIATION 2.5 • n=27 Participants • Addition of number adult and children participants covers number of overall participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
98 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
114 Participants
n=114 Participants
|
|
Fractional exhaled nitric oxide
|
31 ppb
n=114 Participants
|
PRIMARY outcome
Timeframe: 14 daysChange in FeNO value before and after inhaled corticosteroid treatment
Outcome measures
| Measure |
Test Cohort
n=120 Participants
Subjects age 7 to 80 with asthma
Vivatmo pro FeNO Test: Breath gas analysis
|
|---|---|
|
Change in FeNO Value
|
-26.1 percent change
Interval -32.5 to -19.0
|
Adverse Events
Test Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Klaus Müller, Study director
Bosch Healthcare Solutions
Phone: +49 160 90816081
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place