FeNO Detection in Asthma Diagnosis: A New Technology Approach

Summary

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.

Conditions

• Bronchial Asthma
• Airway Disease

Interventions

DIAGNOSTIC_TEST

Chemiluminescent FeNO Analyzer

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.

DIAGNOSTIC_TEST

Electrochemical FeNO Analyzer

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.

Sponsors & Collaborators

• Ruijin Hospital

  collaborator OTHER

• Novlead Inc.

  lead INDUSTRY

Principal Investigators

• Ailing Song · Wuxi Branch of Ruijin Hospital (Xinrui Hospital of Xinwu Distric, Wuxi)

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-09-12

Primary Completion

2025-05-30

Completion

2025-09-01

Countries

• China

Study Locations