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Measurement of FeNO in Young Children With the NIOX VERO

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02661984
First Posted: January 25, 2016
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aerocrine AB
  Purpose

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.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Aerocrine AB:

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


Enrollment: 102
Study Start Date: January 2016
Estimated Study Completion Date: May 31, 2017
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy and Asthmatic 4 - 6 year old children.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02661984


Locations
United States, Arizona
Arizona Allergy & Immunology Research
Gilbert, Arizona, United States
United States, Pennsylvania
Allergy and Asthma Specialists
Blue Bell, Pennsylvania, United States
United States, Texas
Allergy Partners of North Texas
Dallas, Texas, United States
Sponsors and Collaborators
Aerocrine AB
Investigators
Study Director: Kathy Rickard, MD Aerocrine AB
  More Information

Responsible Party: Aerocrine AB
ClinicalTrials.gov Identifier: NCT02661984     History of Changes
Other Study ID Numbers: AER-052
First Submitted: January 5, 2016
First Posted: January 25, 2016
Last Update Posted: May 15, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Aerocrine AB:
FeNO, exhaled nitric oxide

Additional relevant MeSH terms:
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents