Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients

May 11, 2022 updated by: Bosch Healthcare Solutions GmbH

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Clinical Research Center of Alabama
    • California
      • Bakersfield, California, United States, 93301
        • Kern Research, Inc.
    • Maryland
      • White Marsh, Maryland, United States, 21162
        • Chesapeake Clinical Research, Inc.
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • The Clinical Research Center, LLC
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • North Carolina Clinical Research
    • Texas
      • Waco, Texas, United States, 76712
        • Allergy Asthma Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Cohort
Subjects age 7 to 80 with asthma
Diagnostic test: Vivatmo pro FeNO Test
Breath gas analysis
Other Names:
  • Fractional exhaled nitric oxide (FeNo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in FeNO Value
Time Frame: 14 days
Change in FeNO value before and after inhaled corticosteroid treatment
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bosch Healthcare Solutions GmbH

Collaborators

Global BioClinical

Investigators

  • Study Director: Klaus Mueller, Bosch Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2020

Primary Completion (Actual)

December 18, 2020

Study Completion (Actual)

April 13, 2021

Study Registration Dates

First Submitted

June 24, 2020

First Submitted That Met QC Criteria

June 24, 2020

First Posted (Actual)

June 29, 2020

Study Record Updates

Last Update Posted (Actual)

June 6, 2022

Last Update Submitted That Met QC Criteria

May 11, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FeNO US Monitoring Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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