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

Overview

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

Full Title of Study: “Clinical Study of the Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients Responding to Inhaled Corticosteroid (ICS) Treatment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2020

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

Interventions

  • Diagnostic Test: Vivatmo pro FeNO Test
    • Breath gas analysis

Arms, Groups and Cohorts

  • Experimental: Test Cohort
    • Subjects age 7 to 80 with asthma

Clinical Trial Outcome Measures

Primary Measures

  • Change in FeNO value
    • Time Frame: 14 days
    • Change in FeNO value before and after inhaled corticosteroid treatment

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 7 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bosch Healthcare Solutions gmbH
  • Collaborator
    • Global BioClinical
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Neil R. Mucci, 888-659-1221, neil.mucci@globalbioclinical.com

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