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| Name | Class |
|---|---|
| Global BioClinical | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Cohort | Experimental | Subjects age 7 to 80 with asthma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivatmo pro FeNO Test | Diagnostic Test | Breath gas analysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in FeNO Value | Change in FeNO value before and after inhaled corticosteroid treatment | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Mueller | Bosch Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center of Alabama | Birmingham | Alabama | 35209 | United States | ||
| Kern Research, Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Cohort | Subjects age 7 to 80 with asthma Vivatmo pro FeNO Test: Breath gas analysis |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Cohort | Subjects age 7 to 80 with asthma Vivatmo pro FeNO Test: Breath gas analysis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in FeNO Value | Change in FeNO value before and after inhaled corticosteroid treatment | Posted | Geometric Mean | 95% Confidence Interval | percent change | 14 days |
|
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Cohort | Subjects age 7 to 80 with asthma Vivatmo pro FeNO Test: Breath gas analysis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Klaus Müller, Study director | Bosch Healthcare Solutions | +49 160 90816081 | klaush.mueller@de.bosch.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 25, 2020 | Apr 8, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000089142 | Fractional Exhaled Nitric Oxide Testing |
| ID | Term |
|---|---|
| D001944 | Breath Tests |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Bakersfield |
| California |
| 93301 |
| United States |
| Chesapeake Clinical Research, Inc. | White Marsh | Maryland | 21162 | United States |
| The Clinical Research Center, LLC | St Louis | Missouri | 63141 | United States |
| North Carolina Clinical Research | Raleigh | North Carolina | 27607 | United States |
| Allergy Asthma Research Institute | Waco | Texas | 76712 | United States |
| years |
|
| Age, Customized | Addition of number adult and children participants covers number of overall participants | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Fractional exhaled nitric oxide | Median | Inter-Quartile Range | ppb |
|
|
|
| 0 |
| 120 |
| 0 |
| 120 |
| 0 |
| 120 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |