Skip to content

Vivatmo proTM EU-study: FeNO Monitoring in Asthmatic Patients Responding to ICS Treatment

Clinical Study of the Vivatmo proTM for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in Asthmatic Patients Responding to Inhaled Corticosteroid (ICS) Treatment

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05553379
Enrollment
48
Registered
2022-09-23
Start date
2022-03-15
Completion date
2022-10-15
Last updated
2022-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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 weeks and repeat fractional exhaled nitric oxide (FeNO) measured with the Vivatmo pro,

Interventions

DIAGNOSTIC_TESTFeNO measurement

FeNO measurement at each visit

Sponsors

Bosch Healthcare Solutions GmbH
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
7 Years to 80 Years

Inclusion criteria

1. Subject is 7 to 80 years of age. 2. Has asthma 3. Has been identified as a candidate for inhaled corticosteroid (ICS) treatment 4. Is willing and able to perform Vivatmo pro™ testing

Exclusion criteria

1. Subject has used corticosteroids prior to enrollment. 2. Subject has other current serious medical conditions 3. Subject has not been clinically stable for at least 2 weeks prior to the study 4. Subject is unwilling or unable to perform Vivatmo pro testing

Design outcomes

Primary

MeasureTime frameDescription
Change in FeNO Value [Time Frame: 14 days]14 daysChange in FeNO value before and after inhaled corticosteroid treatment

Countries

Czechia, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026