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

Bosch Healthcare

Status: Completed

Conditions: Asthma; Asthma in Children

Treatments: Diagnostic Test: Vivatmo pro FeNO Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT04450108

FeNO US Monitoring Study

Details and patient eligibility

About

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

Full 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

Enrollment: 122 patients

Sex: All

Ages: 7 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

122 participants in 1 patient group

Test Cohort

Experimental group

Description:

Subjects age 7 to 80 with asthma

Treatment:

Diagnostic Test: Vivatmo pro FeNO Test