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

Active, not recruiting

• Conditions: Asthma
• Interventions: Diagnostic Test: FeNO measurement

• Registration Number: NCT05553379
• Lead Sponsor: Bosch Healthcare Solutions GmbH

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 Timeline

• Study Start: 2022-03-15
• Status Verified: 2022-09
• Primary Completion: 2022-09-15
• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-21
• Last Update Submitted: 2022-09-21
• Study First Posted: 2022-09-23
• Last Update Posted: 2022-09-23
• Study Completion: 2022-10-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children 7 to 17	FeNO measurement	Children with asthma
Adults 18 to 80	FeNO measurement	Adults with asthma

Primary Outcome Measures

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

Trial Locations

Locations (5)

MUDr. Ingeborg Vokálova s.r.o; 🇨🇿 Kralupy Nad Vltavou, Czechia

Plicní středisko Teplice s.r.o; 🇨🇿 Teplice, Czechia

Alergologie Skopkova, s.r.o; 🇨🇿 Ostrava, Czechia

Kinderpneumologie und Allergologie im Facharztzentrum; 🇩🇪 Mannheim, Germany

MUDr. Ivan Drnek; 🇨🇿 Ústí Nad Labem, Czechia