Vivatmo proTM EU-study: FeNO Monitoring in Asthmatic Pati... | NCT05553379

Studies
Vivatmo proTM EU-study: FeNO Monitoring in Asthmatic Patients Responding to ICS Treatment

NCT05553379

Sponsor

Bosch Healthcare Solutions GmbH

Status

Unknown status

Last Update Posted

Sep 23, 2022Actual

Enrollment

48Actual

Phase

Not provided

Conditions

Asthma

Interventions

FeNO measurement

Countries

Czechia
Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2022Actual

Primary Completion Date

Sep 15, 2022Estimated

Completion Date

Oct 15, 2022Estimated

First Submitted Date

Sep 21, 2022

First Submission Date that Met QC Criteria

Sep 21, 2022

First Posted Date

Sep 23, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2022

Last Update Posted Date

Sep 23, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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,

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Children 7 to 17		Children with asthma	Diagnostic Test: FeNO measurement
Adults 18 to 80		Adults with asthma	Diagnostic Test: FeNO measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FeNO measurement	Diagnostic Test	FeNO measurement at each visit	Adults 18 to 80 Children 7 to 17

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in FeNO Value [Time Frame: 14 days]	Change in FeNO value before and after inhaled corticosteroid treatment	14 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with Asthma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MUDr. Ingeborg Vokálova s.r.o		Kralupy nad Vltavou		27801	Czechia
Alergologie Skopkova, s.r.o

IPD Sharing Statement Module

Plan to Share IPD

Description

Registration study for internal use only.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Nov 22, 2022
Reset	Sep 28, 2023

Submission Tracking

Estimated Results First Submitted Date

Nov 22, 2022

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Nov 22, 2022			Sep 28, 2023

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided