AsthmaNCT04450108
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
A study testing Vivatmo pro FeNO Test in people with Asthma and Asthma in Children, run by Bosch Healthcare Solutions GmbH at 6 sites in United States.
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, Asthma in Children
- What is being tested?
- Vivatmo pro FeNO Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 6 sitesUnited States
- Study dates
- 8 Sep 2020to 13 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Child, Adult, Older adult
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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Kern Research, Inc.
Bakersfield, California, 93301
Clinical Research Center of Alabama
Birmingham, Alabama, 35209
North Carolina Clinical Research
Raleigh, North Carolina, 27607
The Clinical Research Center, LLC
St Louis, Missouri, 63141
Allergy Asthma Research Institute
Waco, Texas, 76712
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, 21162
About this study
Official title: Clinical Study of the Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. 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, Asthma in Children
- Being tested
- Vivatmo pro FeNO Test
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivatmo pro FeNO TestDiagnostic test
Also called Fractional exhaled nitric oxide (FeNo)
Breath gas analysis
| Study group | Role | What they receive |
|---|---|---|
| Test Cohort | Experimental | Subjects age 7 to 80 with asthma Receives: Diagnostic Test: Vivatmo pro FeNO Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FeNO Value
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 posted29 Jun 2020
- Study start8 Sep 2020
- Primary completion18 Dec 2020
- Study completion13 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bosch Healthcare Solutions GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Global BioClinical
- Responsible party
- Sponsor
- Investigators
- Klaus Mueller, Study director, Bosch Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450108
- Sponsor's protocol ID
- FeNO US Monitoring Study
- Status last verified
- May 2022
- First submitted
- 24 Jun 2020
- Last updated
- 6 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients Responding to Inhaled Corticosteroid (ICS) Treatment
- ClinicalTrials.gov ID
- NCT04450108
- Acronym / sponsor ID
- FeNO US Monitoring Study
- Conditions
- Asthma, Asthma in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Bosch Healthcare Solutions GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Global BioClinical
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 13 Apr 2021 (actual)
- First posted
- 29 Jun 2020 (actual)
- Results
- Posted 6 Jun 2022
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Cohort | Experimental | Diagnostic Test: Vivatmo pro FeNO TestSubjects age 7 to 80 with asthma |
Who may qualify
- Ages
- 7 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Vivatmo pro FeNO TestAlso: Fractional exhaled nitric oxide (FeNo)Breath gas analysis | Diagnostic test | Test Cohort |
Primary outcome
Change in FeNO Value
Time frame: 14 days
Change in FeNO value before and after inhaled corticosteroid treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
Recruiting
THERMotherapy Against Persistent Bacterial LUNG Infections
Lung Diseases, Obstructive, Bronchiectasis
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Klaus Mueller study director
Bosch Healthcare
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vivatmo pro FeNO Test in people with Asthma and Asthma in Children, run by Bosch Healthcare Solutions GmbH at 6 sites in United States.
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: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
Yes. Results are posted in the registry (first posted 6 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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). 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 6 Jun 2022; AzTrials last refreshed its copy on 8 Nov 2026.