Measurement of FeNO in Young Children With the NIOX VERO
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|ClinicalTrials.gov Identifier: NCT02661984|
Recruitment Status : Active, not recruiting
First Posted : January 25, 2016
Last Update Posted : May 15, 2017
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 or disease|
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|
|Actual Enrollment :||102 participants|
|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 Start Date :||January 2016|
|Actual Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||May 31, 2017|
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.
- 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.
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
|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|
|Study Director:||Kathy Rickard, MD||Aerocrine AB|