Measurement of FeNO in Young Children With the NIOX VERO

NCT02661984 | Unknown

• 1 other identifier: AER-052
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 3

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.

Conditions

Asthma

Keywords

FeNO, exhaled nitric oxide

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy and Asthmatic 4 - 6 year old children.

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.

Sponsors & Collaborators

• Aerocrine AB: lead

Study Sites (3)

Arizona Allergy & Immunology Research

Gilbert, Arizona, United States

Location

Allergy and Asthma Specialists

Blue Bell, Pennsylvania, United States

Location

Allergy Partners of North Texas

Dallas, Texas, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Kathy Rickard, MD

  Aerocrine AB

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 25, 2016
• Study Start: January 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: May 31, 2017
• Last Updated: May 15, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)