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

Bosch Healthcare Solutions GmbH48 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Asthma

Interventions

FeNO measurementDIAGNOSTIC_TEST

FeNO measurement at each visit

Eligibility

Sex: ALLMin age: 7 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Change in FeNO Value [Time Frame: 14 days]

Change in FeNO value before and after inhaled corticosteroid treatment

Time frame: 14 days

Data from ClinicalTrials.gov

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