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NCT04450108 Clinical Trial

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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04450108
Other study ID # FeNO US Monitoring Study
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 8, 2020
Est. completion date April 13, 2021

Study information
Verified date May 2022
Source Bosch Healthcare Solutions GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 122
Est. completion date April 13, 2021
Est. primary completion date December 18, 2020
Accepts healthy volunteers No
Gender All
Age group 7 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Vivatmo pro FeNO Test
Breath gas analysis

Locations
Country Name City State
United States Kern Research, Inc. Bakersfield California
United States Clinical Research Center of Alabama Birmingham Alabama
United States North Carolina Clinical Research Raleigh North Carolina
United States The Clinical Research Center, LLC Saint Louis Missouri
United States Allergy Asthma Research Institute Waco Texas
United States Chesapeake Clinical Research, Inc. White Marsh Maryland

Sponsors (2)
Lead Sponsor Collaborator
Bosch Healthcare Solutions GmbH Global BioClinical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in FeNO Value Change in FeNO value before and after inhaled corticosteroid treatment 14 days
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