Clinical trial NCT02661984: Measurement of FeNO in Young Children With the NIOX VERO
Official title: A Randomized, Multi-Center, Single-Visit, Clinical Investigation to Assess the Degree of Agreement and Feasibility of Measuring Exhaled Nitric Oxide in Children, Aged 4-6 Years Old, With the NIOX VERO Using the 6 Second Exhalation Mode as Compared With the 10 Second Exhalation Mode
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Keywords: FeNO, exhaled nitric oxide
Lead sponsor: Aerocrine AB
Sponsor class: INDUSTRY
First posted: 2016-01-25
Enrollment: 102
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy and Asthmatic 4 - 6 year old children.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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).

Exclusion Criteria:

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.
6. 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).
7. Has a Parent/Guardian who is unable or unwilling to provide informed consent.

Primary outcomes:
measure: The primary endpoint will be the analysis of the agreement of successful FeNO measurements in the 10 second and the 6 second exhalation modes.
timeFrame: After a single 1-2 hour visit
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Arizona Allergy & Immunology Research
state: Arizona
city: Blue Bell
country: United States
facility: Allergy and Asthma Specialists
state: Pennsylvania
city: Dallas
country: United States
facility: Allergy Partners of North Texas
state: Texas
Study officials:
affiliation: Aerocrine AB
name: Kathy Rickard, MD
role: STUDY_DIRECTOR
References: