Measurement of FeNO in Young Children With the NIOX VERO

NCT ID: NCT02661984

Last Updated: 2017-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-05-31

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.

Conditions

Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy (no pulmonary disease)

Healthy children 4 - 6 years old with no pulmonary disease and not exhibiting respiratory illness or sinusitis.

No interventions assigned to this group

Asthmatic (physician diagnosed)

Asthmatic children 4 - 6 years old not exhibiting acute asthma symptoms, respiratory illness or sinusitis.

No interventions assigned to this group

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aerocrine AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathy Rickard, MD

Role: STUDY_DIRECTOR

Aerocrine AB

Locations

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

Countries

United States

Other Identifiers

AER-052

Identifier Type: -

Identifier Source: org_study_id