Asthma, Asthma in Children
Conditions
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.
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
Interventions
DIAGNOSTIC_TESTVivatmo pro FeNO Test
Breath gas analysis
Sponsors
Global BioClinical
Bosch Healthcare Solutions GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in FeNO Value | 14 days | Change in FeNO value before and after inhaled corticosteroid treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Cohort Subjects age 7 to 80 with asthma
Vivatmo pro FeNO Test: Breath gas analysis | 114 |
| Total | 114 |
Baseline characteristics
| Characteristic | Test Cohort |
|---|---|
| Age, Continuous | 34.3 years STANDARD_DEVIATION 16.9 |
| Age, Customized Adults | 41.4 years STANDARD_DEVIATION 13.6 |
| Age, Customized Children | 12.6 years STANDARD_DEVIATION 2.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 98 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fractional exhaled nitric oxide | 31 ppb |
| Region of Enrollment United States | 114 Participants |
| Sex: Female, Male Female | 60 Participants |
| Sex: Female, Male Male | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 120 |
| other Total, other adverse events | 0 / 120 |
| serious Total, serious adverse events | 0 / 120 |
Outcome results
Primary
Change in FeNO Value
Change in FeNO value before and after inhaled corticosteroid treatment
Time frame: 14 days
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Test Cohort | Change in FeNO Value | -26.1 percent change |
Comparison: Since the effect size of the change (mean change / standard deviation) is on the order of 1 (resulting in N=10 and 13 for power = 80% and 90%, respectively) and therefore large, the sample size is not determined by the primary objective but by the necessity to achieve representative data of FeNO measurement data over all age groups, measurement ranges (\<, ≥ cut off) and sites. Thus, 120 subjects will be recruited.p-value: <0.001ANCOVA