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

Primary Purpose

Asthma, Asthma in Children

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vivatmo pro FeNO Test
Sponsored by
Bosch Healthcare Solutions GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Asthma

Eligibility Criteria

7 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinical Research Center of Alabama
  • Kern Research, Inc.
  • Chesapeake Clinical Research, Inc.
  • The Clinical Research Center, LLC
  • North Carolina Clinical Research
  • Allergy Asthma Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Test Cohort

Arm Description

Subjects age 7 to 80 with asthma

Outcomes

Primary Outcome Measures

Change in FeNO Value
Change in FeNO value before and after inhaled corticosteroid treatment

Secondary Outcome Measures

Full Information

First Posted
June 24, 2020
Last Updated
May 11, 2022
Sponsor
Bosch Healthcare Solutions GmbH
Collaborators
Global BioClinical
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1. Study Identification

Unique Protocol Identification Number
NCT04450108
Brief Title
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 8, 2020 (Actual)
Primary Completion Date
December 18, 2020 (Actual)
Study Completion Date
April 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bosch Healthcare Solutions GmbH
Collaborators
Global BioClinical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Asthma in Children

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Cohort
Arm Type
Experimental
Arm Description
Subjects age 7 to 80 with asthma
Intervention Type
Diagnostic Test
Intervention Name(s)
Vivatmo pro FeNO Test
Other Intervention Name(s)
Fractional exhaled nitric oxide (FeNo)
Intervention Description
Breath gas analysis
Primary Outcome Measure Information:
Title
Change in FeNO Value
Description
Change in FeNO value before and after inhaled corticosteroid treatment
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is 7 to 80 years of age. Has asthma Has been identified as a candidate for inhaled corticosteroid (ICS) treatment Is willing and able to perform Vivatmo pro™ testing Exclusion Criteria: Subject has used corticosteroids prior to enrollment. Subject has other current serious medical conditions Subject has not been clinically stable for at least 2 weeks prior to the study Subject is unwilling or unable to perform Vivatmo pro testing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Mueller
Organizational Affiliation
Bosch Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Kern Research, Inc.
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Chesapeake Clinical Research, Inc.
City
White Marsh
State/Province
Maryland
ZIP/Postal Code
21162
Country
United States
Facility Name
The Clinical Research Center, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
North Carolina Clinical Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Allergy Asthma Research Institute
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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