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

Bosch Healthcare

Status: Active, not recruiting

Conditions: Asthma

Treatments: Diagnostic Test: FeNO measurement

Study type: Observational

Funder types: Industry

Identifiers

NCT05553379

MDQ-01.736-010-02-EBA-PAM

Details and patient eligibility

About

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

Full 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,

Enrollment: 48 patients

Sex: All

Ages: 7 to 80 years old

Volunteers: No 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

Trial design

48 participants in 2 patient groups

Children 7 to 17

Description:

Children with asthma

Treatment:

Diagnostic Test: FeNO measurement

Adults 18 to 80

Description:

Adults with asthma

Treatment:

Diagnostic Test: FeNO measurement