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Introduction <p>Fractional exhaled nitric oxide (FeNO) is an important type&#xa0;2 (T2) asthma biomarker. Home-based FeNO monitoring can provide longitudinal data better reflecting the variable nature of T2 inflammation versus single-point data. We sought to compare longitudinal mean FeNO and variability (CV) in relation to asthma control, and to compare detection rate of T2<sub>FeNO</sub> inflammation at diagnostic (≥ 40&#xa0;ppb in GINA&#xa0;1) and on-treatment (≥ 25&#xa0;ppb in GINA&#xa0;2–5) cutoffs during home versus clinic measurements.</p> Methods <p>This was an observational study with once-daily home-based FeNO (Vivatmo&#xa0;<i>me</i>) and symptom diary in patients with asthma of different GINA steps performed over 3&#xa0;months. Clinic FeNO, forced expiratory volume in 1&#xa0;s (FEV<sub>1</sub>), and 5-item asthma control questionnaire (ACQ-5) scores were also collected at two visits (enrolment/study end).</p> Results <p>We enrolled 85 patients (<i>n</i> = 23 step&#xa0;1, <i>n</i> = 37 steps 2–3, and <i>n</i> = 25 steps 4–5). Mean FeNO over 3&#xa0;months was highest in uncontrolled steps 4–5 (<i>p</i> = 0.006), and FeNO variability in steps 2–3 (<i>p</i> = 0.046). Subjects with optimal control (ACQ &lt; 0.75 both visits) had comparable mean FeNO values, but fewer patients with CV above the median vs. suboptimally controlled patients (39.1% vs. 54.1%; <i>p</i> = 0.03). In GINA&#xa0;1, FeNO CV was lower in optimally controlled patients (<i>p</i> = 0.10). Mean FeNO was higher on symptomatic asthma days, particularly in step&#xa0;1 (<i>p</i> = 0.002), with similar trends during loss of asthma control phases. Home FeNO increased the detection rate of T2<sub>FeNO</sub> inflammation at a diagnostic cutoff (≥ 40&#xa0;ppb, step&#xa0;1) from 8.7% (clinic FeNO) to 47.8% of subjects, and of on-treatment T2<sub>FeNO</sub> inflammation in GINA steps&#xa0;2–3 and 4–5 from 58.3% to 83.3%, and 64% to 96%, respectively.</p> Conclusion <p>Home-based FeNO provides important information about airway inflammation, distinct and complementary to symptom control. Detection of T2<sub>FeNO</sub> inflammation is facilitated at all GINA steps at diagnostic and predictive/prognostic cutoffs, with important implications for management and diagnosis.</p> Trial Registration <p>German Clinical Trial Register (DRKS) DRKS00029118, registered July&#xa0;1, 2022.</p>

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Home-Based FeNO Monitoring with the Vivatmo me Device Reveals Type 2 Inflammatory Patterns of Patients with Asthma at Different Treatment Steps: The FeNO@Home Study

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  • 发表日期：

    2025年12月10日

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  • Kai M. Beeh,
  • Tim Harrison,
  • Enrico Heffler,
  • Hartmut Timmermann,
  • Stephan Weber,
  • Sandra Wegner

摘要

Introduction

Fractional exhaled nitric oxide (FeNO) is an important type 2 (T2) asthma biomarker. Home-based FeNO monitoring can provide longitudinal data better reflecting the variable nature of T2 inflammation versus single-point data. We sought to compare longitudinal mean FeNO and variability (CV) in relation to asthma control, and to compare detection rate of T2FeNO inflammation at diagnostic (≥ 40 ppb in GINA 1) and on-treatment (≥ 25 ppb in GINA 2–5) cutoffs during home versus clinic measurements.

Methods

This was an observational study with once-daily home-based FeNO (Vivatmo me) and symptom diary in patients with asthma of different GINA steps performed over 3 months. Clinic FeNO, forced expiratory volume in 1 s (FEV1), and 5-item asthma control questionnaire (ACQ-5) scores were also collected at two visits (enrolment/study end).

Results

We enrolled 85 patients (n = 23 step 1, n = 37 steps 2–3, and n = 25 steps 4–5). Mean FeNO over 3 months was highest in uncontrolled steps 4–5 (p = 0.006), and FeNO variability in steps 2–3 (p = 0.046). Subjects with optimal control (ACQ < 0.75 both visits) had comparable mean FeNO values, but fewer patients with CV above the median vs. suboptimally controlled patients (39.1% vs. 54.1%; p = 0.03). In GINA 1, FeNO CV was lower in optimally controlled patients (p = 0.10). Mean FeNO was higher on symptomatic asthma days, particularly in step 1 (p = 0.002), with similar trends during loss of asthma control phases. Home FeNO increased the detection rate of T2FeNO inflammation at a diagnostic cutoff (≥ 40 ppb, step 1) from 8.7% (clinic FeNO) to 47.8% of subjects, and of on-treatment T2FeNO inflammation in GINA steps 2–3 and 4–5 from 58.3% to 83.3%, and 64% to 96%, respectively.

Conclusion

Home-based FeNO provides important information about airway inflammation, distinct and complementary to symptom control. Detection of T2FeNO inflammation is facilitated at all GINA steps at diagnostic and predictive/prognostic cutoffs, with important implications for management and diagnosis.

Trial Registration

German Clinical Trial Register (DRKS) DRKS00029118, registered July 1, 2022.