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

Sponsor
Bosch Healthcare Solutions GmbH (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05553379
Collaborator
(none)
48
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
48 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Clinical Study of the Vivatmo proTM for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in Asthmatic Patients Responding to Inhaled Corticosteroid (ICS) Treatment
Actual Study Start Date :
Mar 15, 2022
Anticipated Primary Completion Date :
Sep 15, 2022
Anticipated Study Completion Date :
Oct 15, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Change in FeNO Value [Time Frame: 14 days] [14 days]

    Change in FeNO value before and after inhaled corticosteroid treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 80 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 MUDr. Ingeborg Vokálova s.r.o Kralupy Nad Vltavou Czechia 27801
2 Alergologie Skopkova, s.r.o Ostrava Czechia 70900
3 Plicní středisko Teplice s.r.o Teplice Czechia 941501
4 MUDr. Ivan Drnek Ústí Nad Labem Czechia 40001
5 Kinderpneumologie und Allergologie im Facharztzentrum Mannheim Germany 68161

Sponsors and Collaborators

  • Bosch Healthcare Solutions GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bosch Healthcare Solutions GmbH
ClinicalTrials.gov Identifier:
NCT05553379
Other Study ID Numbers:
  • MDQ-01.736-010-02-EBA-PAM
First Posted:
Sep 23, 2022
Last Update Posted:
Sep 23, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 23, 2022