FeNO Detection in Asthma Diagnosis: A New Technology Approach

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovlead Inc.

About this trial

The detection of exhaled nitric oxide (FeNO) represents a non-invasive, safe, and rapid approach for assessing endogenous nitric oxide (NO) levels within the airway. FeNO concentrations are closely associated with airway inflammation and hyperresponsiveness, and are currently recognized as biomarkers indicative of type II airway inflammation. Recent advancements in nitric oxide detection technology for both upper and lower airways, as well as for small and large airways, have provided significant insights for the diagnosis and management of conditions such as bronchial asthma, chronic cough, upper airway diseases, chronic obstructive pulmonary disease, and even rare airway disorders. Presently, FeNO measurement is frequently employed in the differential diagnosis and monitoring of airway inflammatory diseases.

The FeNO test is conducted using a FeNO test analyzer. Internationally, FeNO detection analyzers utilize three primary methodologies: chemiluminescence, laser, and electrochemical techniques. Among these, chemiluminescence is regarded as the "gold standard" globally. However, due to technical constraints, this methodology has not been clinically accessible within domestic settings. In China, the electrochemical FeNO analyzer is predominantly utilized, characterized by its compact size and portability. Nonetheless, this method necessitates patient cooperation during inhalation and exhalation, rendering it impractical for individuals who are unable to comply, such as children, the elderly, and severely ill patients. Consequently, FeNO detection poses significant challenges for these populations in China, representing a notable clinical gap.

The newly implemented technology employs an innovative domestic chemiluminescence FeNO analyzer, which is exclusively available in China. This analyzer, owing to its methodological advantages, is capable of obtaining FeNO detection values from patients' natural breathing patterns, facilitating rapid response and comprehensive FeNO assessment without requiring patient cooperation. This approach, referred to as the "Tidal-breathing of FeNO" enables the completion of FeNO assessments in patients who are unable to engage in inspiratory and expiratory maneuvers. This advancement is anticipated to enhance the diagnostic accuracy of airway inflammation in this demographic, thereby facilitating early diagnosis, precise treatment, and improved management of disease progression.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants must be a minimum of 18 years of age, irrespective of gender;

Individuals must possess a diagnosis of bronchial asthma that aligns with the international GINA 2023 diagnostic criteria;

Respiratory symptoms must have been evident for at least 6 weeks;

Participants should either have no history of smoking or have discontinued smoking for a period exceeding 5 years.

Disqualifiers

The concurrent use of additional asthma medications (such as glucocorticoids) alongside short-acting bronchodilators within the prior 4 weeks;

A diagnosis of respiratory infection within the preceding 4 weeks;

Conditions such as pregnancy, lactation, or menstruation;

Participation in other clinical research studies;

Trial design

Design model

Sequential

Treatments tested in this trial

  • Chemiluminescent FeNO Analyzer

    Diagnostic test

    A novel chemiluminescence FeNO Analyzer has been developed, capable of measuring both FeNO50 and FeNO during tidal breathing. Each participant underwent three testing sessions, with the results averaged, and the sequence of tests was randomized.

  • Electrochemical FeNO Analyzer

    Diagnostic test

    Electrochemical FeNO analyzers are employed in clinical settings for the measurement of FeNO50. Each participant underwent three testing sessions, with the results averaged, and the sequence of tests was randomized.

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: Asthma PatientsOther 2 interventions
Group B: HealthyOther 2 interventions

Trial outcomes

Primary outcomes

1

Performance Assessment of FeNO Chemiluminescence Analyzer

Assessment of the performance of the FeNO chemiluminescence analyzer, focusing on repeatability (coefficient of variation, CV), sensitivity, specificity, and receiver operating characteristic (ROC) curves

Time frame
Through study completion, an average of 6 months

Secondary outcomes

1

Consistency Evaluation Between FeNO Analyzers

Evaluation of the consistency between the chemiluminescence FeNO analyzer and the electrochemical FeNO analyzers, utilizing correlation and Bland-Altman analysis.

Time frame
through study completion, an average of 6 months

Other outcomes

1

Cut-off of Tidal Breathing of FeNO

Analysis of the Tidal Breathing of FeNO for the chemiluminescence FeNO analyzer, employing the ROC method to identify the optimal cut-off value

Time frame
through study completion, an average of 6 months

Sponsors and contacts

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Novlead Inc.

Lead sponsor

Ruijin Hospital

Collaborator