Background: Exhaled nitric oxide (FeNO) is a validated marker of eosinophilic inflammation. Fenom ProTM is a novel FDA-cleared monitor for FeNO. The American Thoracic Guidelines from 2005 recommend at least 6 s exhalation for adults and in some cases up to 10 s, and 4 s for children, and that the average of the first two valid exhalations is taken as the FeNO value. Methods: Clinical precision, 6 versus 10 s exhalations, the first versus the average of the first two valid exhalation methods comparison were evaluated for Fenom ProTM, as well as a methods comparison to the NIOX VERO® monitor. Results: The intent-to-treat population (n = 126) consisted of 83 adults, and 43 pediatric subjects with 16 subjects under 12 years of age. Clinical precision for 10 s exhalations on Fenom ProTM was excellent with a within-subject standard deviation (SD) range of 0.57–3.73 ppb and mean coefficient of variation (CV) range of 4.21% to 9.65%. The clinical precision for the separate adult and pediatric groups as well as for the 6 s exhalations were similar. The 10 and 6 s exhalation comparisons and one versus the average of two valid exhalations showed a high level of agreement. The Fenom ProTM and the NIOX VERO® monitors also demonstrated a high level of agreement with the values from the latter slightly lower (mean bias of −3.2 ppb). Conclusion: Fenom ProTM demonstrated eminently acceptable performance supporting its clinical utility. The data suggests that 6 s exhalations can be used in adults and children, and that one exhalation is adequate rather than obtaining the average of two exhalations on Fenom ProTM.

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Background: Asthma is a complex syndrome with multiple domains including symptoms, lung function, asthma control, and airway inflammation. A study of Fenom PRO™, a novel monitor for exhaled nitric oxide (FeNO), provided an opportunity to look at concordance/discordance (C/D) for changes in multiple asthma domains over a 2-week period after corticosteroid therapy. Methods: Non-steroid-treated adults and children with uncontrolled asthma had asthma domain measures, (FeNO), forced expired volume in 1 s (FEV 1), the 6-item Asthma Control Questionnaire scores (ACQ6), and daily asthma symptoms, assessed before and after a 2-week course of corticosteroids. Asthma symptoms were assessed using a custom novel twice-daily symptom scale (ASX). C/D bidirectional changes in all domains were calculated around both the zero point, and around the minimal important difference (MID) in relevant subjects. Results: There was a highly significant fall in mean FeNO of 51.7% over 2 weeks (p < 0.0001) accompanied by significant improvements in mean FEV 1 , ACQ6 and ASX scores. However, C/D between individual domains varied considerably between subjects. The C/D between parameters for any change around zero for the combined adults and pediatric population was best for FeNO and ACQ6, 79.3/20.7% while FEV 1 was more discordant than other parameters in general. When considering changes around the minimal important difference (MID) in a subset, the level of concordance increased in general, with FeNO and ACQ6 demonstrating a C/D of 93.5/6.6%. Conclusion: This data demonstrates that the concordance between changes in the asthma domains is often substantially less than 100%. Reasons for this may include different time courses for change of the separate domains, the degree of abnormality for each domain at baseline, as well as intrinsic limitations of each parameter.