AsthmaNCT05553379
Vivatmo proTM EU-study: FeNO Monitoring in Asthmatic Patients Responding to ICS Treatment
An observational study of Asthma, run by Bosch Healthcare Solutions GmbH at 5 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 7 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- FeNO measurement
- How many people
- 48 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 15 Mar 2022to 15 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 80 years
- All sexes
- Child, Adult, Older adult
Study population: Patients with Asthma
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Czechia4 sites
MUDr. Ingeborg Vokálova s.r.o
Kralupy nad Vltavou, 27801
Alergologie Skopkova, s.r.o
Ostrava, 70900
Plicní středisko Teplice s.r.o
Teplice, 941501
MUDr. Ivan Drnek
Ústí nad Labem, 40001
Germany1 site
Kinderpneumologie und Allergologie im Facharztzentrum
Mannheim, 68161
About this study
Official title: Clinical Study of the Vivatmo proTM for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in Asthmatic Patients Responding to Inhaled Corticosteroid (ICS) Treatment
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
- Asthma
- Being tested
- FeNO measurement
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeNO measurementDiagnostic test
FeNO measurement at each visit
| Study group | Role | What they receive |
|---|---|---|
| Children 7 to 17 | Children with asthma Receives: Diagnostic Test: FeNO measurement | |
| Adults 18 to 80 | Adults with asthma Receives: Diagnostic Test: FeNO measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FeNO Value [Time Frame: 14 days]
Change in FeNO value before and after inhaled corticosteroid treatment
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start15 Mar 2022
- Primary completion15 Sep 2022 (estimated)
- Study completion15 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bosch Healthcare Solutions GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553379
- Sponsor's protocol ID
- MDQ-01.736-010-02-EBA-PAM
- Status last verified
- Sep 2022
- First submitted
- 21 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Registration study for internal use only.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Vivatmo proTM for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in Asthmatic Patients Responding to Inhaled Corticosteroid (ICS) Treatment
- ClinicalTrials.gov ID
- NCT05553379
- Acronym / sponsor ID
- MDQ-01.736-010-02-EBA-PAM
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Bosch Healthcare Solutions GmbHIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Sep 2022 (estimated)
- Study completion
- 15 Oct 2022 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children 7 to 17 | – | Diagnostic Test: FeNO measurementChildren with asthma |
| Adults 18 to 80 | – | Diagnostic Test: FeNO measurementAdults with asthma |
Who may qualify
- Ages
- 7 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Asthma
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FeNO measurementFeNO measurement at each visit | Diagnostic test | Adults 18 to 80, Children 7 to 17 |
Primary outcome
Change in FeNO Value [Time Frame: 14 days]
Time frame: 14 days
Change in FeNO value before and after inhaled corticosteroid treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Individual participant dataSharing planned: No. Registration study for internal use only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Bosch Healthcare Solutions GmbH at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Czechia, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FeNO Value [Time Frame: 14 days] (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.