Status unknownNCT05553379Updated Sep 23, 2022

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

An observational study in Asthma, sponsored by Bosch Healthcare Solutions GmbH. Status unknown at 5 sites in 2 countries. Open to participants aged 7 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-09-23.

Sponsored by Bosch Healthcare Solutions GmbH · Observational

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Active, not recruiting — may be out of date.

Study type: Observational
Model: Other
Time perspective: Other
Enrollment: 48
Ages: 7 Years to 80 Years
Sex: All

Study summary

This is a multi-center study to evaluate fractional exhaled nitric oxide (FeNO) measured with the Vivatmo pro in adult and pediatric subjects.

Read the 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,

Conditions studied

Asthma

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In context

Asthma

4,012 studies on the registry are indexed under Asthma; 514 are open to participants now.

This study's enrollment of 48 is below the median of 150 across 993 observational studies indexed under Asthma.

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Lead sponsor

Bosch Healthcare Solutions GmbH is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 7 Years to 80 Years
Sexes eligible: All
Sampling method: Non-probability sample

Study population

Patients with Asthma

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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 criteria

Exclusion Criteria:

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

Study design

Observational model: Other
Time perspective: Other
Enrollment: 48 participants (actual)
Patient registry: No

Groups and cohorts

Children 7 to 17
Children with asthma
Diagnostic Test: FeNO measurement
Adults 18 to 80
Adults with asthma
Diagnostic Test: FeNO measurement

Interventions

Diagnostic testFeNO measurement
FeNO measurement at each visit

What researchers measure

Primary outcomes

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

Study locations

5 sites

MUDr. Ingeborg Vokálova s.r.o
Kralupy nad Vltavou, 27801, Czechia
Alergologie Skopkova, s.r.o
Ostrava, 70900, Czechia
Plicní středisko Teplice s.r.o
Teplice, 941501, Czechia
MUDr. Ivan Drnek
Ústí nad Labem, 40001, Czechia
Kinderpneumologie und Allergologie im Facharztzentrum
Mannheim, 68161, Germany

References and documents

Individual participant data

Plan to share: No — Registration study for internal use only.

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05553379
Lead sponsor: Bosch Healthcare Solutions GmbH
Responsible party: Sponsor
First posted: Sep 23, 2022
Start date: Mar 15, 2022
Primary completion: Sep 15, 2022 (estimated)
Completion: Oct 15, 2022 (estimated)
Last update: Sep 23, 2022

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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