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

Clinical Study of the Vivatmo proTM for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in Asthmatic Patients Responding to Inhaled Corticosteroid (ICS) Treatment

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

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma
• Intervention / Treatment: Diagnostic test: FeNO measurement

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 Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Czechia
  • Kralupy Nad Vltavou, Czechia, 27801
    • MUDr. Ingeborg Vokálova s.r.o
  • Ostrava, Czechia, 70900
    • Alergologie Skopkova, s.r.o
  • Teplice, Czechia, 941501
    • Plicni Stredisko Teplice S.R.O
  • Ústí Nad Labem, Czechia, 40001
    • MUDr. Ivan Drnek
• Germany
  • Mannheim, Germany, 68161
    • Kinderpneumologie und Allergologie im Facharztzentrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Asthma

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children 7 to 17; Children with asthma	Diagnostic test: FeNO measurement; FeNO measurement at each visit
Adults 18 to 80; Adults with asthma	Diagnostic test: FeNO measurement; FeNO measurement at each visit

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bosch Healthcare Solutions GmbH

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Anticipated): September 15, 2022
• Study Completion (Anticipated): October 15, 2022

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: MDQ-01.736-010-02-EBA-PAM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Registration study for internal use only.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No