Skip to main content
OpenTrials
Completed

NCT Number: NCT04450108

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Asthma in Children Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

7 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Center of Alabama, Birmingham, Alabama, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Vivatmo pro FeNO Test

Diagnostic Test

Breath gas analysis

Other names: Fractional exhaled nitric oxide (FeNo)

Primary outcomes

  1. Change in FeNO Value

    Time frame: 14 days

    Change in FeNO value before and after inhaled corticosteroid treatment

Sponsors and collaborators

Lead sponsor

Bosch Healthcare Solutions GmbH

Industry

Collaborators

  • Global BioClinical

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 29, 2020
Registry last updated
Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.