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

Not Applicable

Completed

• Conditions: Asthma in Children; Asthma
• Interventions: Diagnostic Test: Vivatmo pro FeNO Test

• Registration Number: NCT04450108
• Lead Sponsor: Bosch Healthcare Solutions GmbH

Brief Summary

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 Timeline

• Study First Submitted: 2020-06-24
• Study First Submitted QC: 2020-06-24
• Study First Posted: 2020-06-29
• Study Start: 2020-09-08
• Primary Completion: 2020-12-18
• Study Completion: 2021-04-13
• Results First Submitted: 2022-04-12
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-11
• Last Update Submitted: 2022-05-11
• Results First Posted: 2022-06-06
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test Cohort	Vivatmo pro FeNO Test	Subjects age 7 to 80 with asthma

Primary Outcome Measures

Name	Time	Method
Change in FeNO Value	14 days	Change in FeNO value before and after inhaled corticosteroid treatment

Trial Locations

Locations (6)

North Carolina Clinical Research; 🇺🇸 Raleigh, North Carolina, United States

Clinical Research Center of Alabama; 🇺🇸 Birmingham, Alabama, United States

Kern Research, Inc.; 🇺🇸 Bakersfield, California, United States

Chesapeake Clinical Research, Inc.; 🇺🇸 White Marsh, Maryland, United States

The Clinical Research Center, LLC; 🇺🇸 Saint Louis, Missouri, United States

Allergy Asthma Research Institute; 🇺🇸 Waco, Texas, United States