Vivatmo proTM EU-study: FeNO Monitoring in Asthmatic Patients Responding to ICS Treatment
- Conditions
- Asthma
- 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,
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 48
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
MUDr. Ingeborg Vokálova s.r.o
🇨🇿Kralupy Nad Vltavou, Czechia
Alergologie Skopkova, s.r.o
🇨🇿Ostrava, Czechia
Plicní středisko Teplice s.r.o
🇨🇿Teplice, Czechia
MUDr. Ivan Drnek
🇨🇿Ústí Nad Labem, Czechia
Kinderpneumologie und Allergologie im Facharztzentrum
🇩🇪Mannheim, Germany
MUDr. Ingeborg Vokálova s.r.o🇨🇿Kralupy Nad Vltavou, Czechia