Measurement of FeNO in Young Children With the NIOX VERO

Asthma Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Asthma

• NCT number: NCT02661984
• Study type: Observational
• Source: Aerocrine AB
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2016
• Completion date: May 31, 2017