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Lead
Aerocrine AB
The primary objective is to assess the degree of agreement of FeNO measured with the NIOX VERO using the 6-sec and 10-sec modes.
The secondary objectives of the Clinical Investigation are to:
* Assess the ability of participants to use the NIOX VERO for measuring FeNO in both exhalation modes, and
* Compare the repeatability of FeNO measured with the NIOX VERO in both exhalation modes.
Participants will attempt 2 measurements taken using the 6-sec mode followed by 2 measurements using the 10 second exhalation mode or vice versa.
Age
4–6
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
1. Male or female 4, 5 and 6 years old,
2. Primary Language: English or Spanish, and
3. Healthy (e.g., no pulmonary disease) or Asthmatic (if asthmatic, they must have a physician diagnosis of asthma).
You may not be if
1. Pulmonary Disease Status: Any disease other than asthma.
2. In the opinion of the investigator, has severe or uncontrolled asthma (defined as having a) 2 or more exacerbations within the last year that required the use of systemic corticosteroids, or b) 1 or more hospitalizations, ICU stays or mechanical ventilations within the last year).
3. Has taken their reliever inhaler within 4 - 6 hours from the FeNO measurements.
4. Has acute asthma symptoms, respiratory illness (e.g. cold, flu), or sinusitis.
5. Has had food or beverage intake (other than water) or has participated in strenuous exercise within 1 hour prior to FeNO measurement.
7. Has a Parent/Guardian who is unable or unwilling to provide informed consent.
Clareo Health | Measurement of FeNO in Young Children With the NIOX VERO
