Vivatmo proTM EU-study: FeNO Monitoring in Asthmatic Patients Responding to ICS Treatment
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 |
---|---|---|
|
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
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
- Change in FeNO Value [Time Frame: 14 days] [14 days]
Change in FeNO value before and after inhaled corticosteroid treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is 7 to 80 years of age.
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Has asthma
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Has been identified as a candidate for inhaled corticosteroid (ICS) treatment
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Is willing and able to perform Vivatmo pro™ testing
Exclusion Criteria:
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Subject has used corticosteroids prior to enrollment.
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Subject has other current serious medical conditions
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Subject has not been clinically stable for at least 2 weeks prior to the study
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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.- MDQ-01.736-010-02-EBA-PAM