Measurement of FeNO in Young Children With the NIOX VERO

Status unconfirmed

Conditions studied: Asthma

In brief

FeNO measurements provide the physician with means of evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. Interpretation of FeNO profiles is based on the nitric oxide plateau. To achieve plateau, the duration of exhalation must be sufficient (at least 4 seconds for children \<12 years and \> 6 seconds for children \> 12 years (ATS/ERS, 2005). Measurement of FeNO using the 6-sec mode may provide a viable alternative in children as young as age 4 years who may have difficulty maintaining exhalation for a full 10 seconds.

Key facts

Study ID

NCT02661984

Run by

Aerocrine AB

People needed

102

Starts

2016-01-01

Expected to finish

2017-05-31

Last updated by the study team

2017-05-15

Who can join

Age: 4 and older, up to 6. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female 4, 5 and 6 years old,
• Primary Language: English or Spanish, and
• Healthy (e.g., no pulmonary disease) or Asthmatic (if asthmatic, they must have a physician diagnosis of asthma).

You may not qualify if…

• Pulmonary Disease Status: Any disease other than asthma.
• 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).
• Has taken their reliever inhaler within 4 - 6 hours from the FeNO measurements.
• Has acute asthma symptoms, respiratory illness (e.g. cold, flu), or sinusitis.
• Has had food or beverage intake (other than water) or has participated in strenuous exercise within 1 hour prior to FeNO measurement.
• Has a family relationship with the Operator or Study Personnel (persons who are family members of the Operator or Study Personnel are not eligible to participate).
• Has a Parent/Guardian who is unable or unwilling to provide informed consent.

Where it is running

• Arizona Allergy & Immunology Research — Gilbert, Arizona, United States
• Allergy and Asthma Specialists — Blue Bell, Pennsylvania, United States
• Allergy Partners of North Texas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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