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

Bosch Healthcare Solutions GmbH122 enrolled

Overview

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

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

122

Conditions

Asthma Asthma in Children

Interventions

Vivatmo pro FeNO TestDIAGNOSTIC_TEST

Breath gas analysis

Eligibility

Sex: ALLMin age: 7 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (6)

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

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Change in FeNO Value

Change in FeNO value before and after inhaled corticosteroid treatment

Time frame: 14 days

Data from ClinicalTrials.gov

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