Ignite Creation Date:
2024-05-06 @ 6:07 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05553379
Status:
UNKNOWN
Last Update Posted:
2022-09-23
First Post:
2022-09-21
Brief Title:
Vivatmo proTM EU-study FeNO Monitoring in Asthmatic Patients Responding to ICS Treatment
Sponsor:
Bosch Healthcare Solutions GmbH
Organization:
Bosch Healthcare Solutions GmbH
Study Overview
Official Title:
Clinical Study of the Vivatmo proTM for Fractional Exhaled Nitric Oxide FeNO Monitoring in Asthmatic Patients Responding to Inhaled Corticosteroid ICS Treatment
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None