Measurement of FeNO in Young Children With the NIOX VERO

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

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.

Study Overview

• Status: Unknown
• Conditions: Asthma

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.

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy and Asthmatic 4 - 6 year old children.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy (no pulmonary disease); Healthy children 4 - 6 years old with no pulmonary disease and not exhibiting respiratory illness or sinusitis.
Asthmatic (physician diagnosed); Asthmatic children 4 - 6 years old not exhibiting acute asthma symptoms, respiratory illness or sinusitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoint will be the analysis of the agreement of successful FeNO measurements in the 10 second and the 6 second exhalation modes.	This is a single visit study.	After a single 1-2 hour visit

Collaborators and Investigators

• Sponsor: Aerocrine AB

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ACTUAL): November 1, 2016
• Study Completion (ANTICIPATED): May 31, 2017

Study Registration Dates

• First Submitted: January 5, 2016
• First Submitted That Met QC Criteria: January 20, 2016
• First Posted (ESTIMATE): January 25, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 15, 2017
• Last Update Submitted That Met QC Criteria: May 11, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: FeNO, exhaled nitric oxide
• Other Study ID Numbers: AER-052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO