FeNO Detection in Asthma Diagnosis: A New Technology Approach

NCT06852911 | Recruiting

• 1 other identifier: FeNO2403-1.3
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

FeNO; Bronchial asthma; Tidal breathing

Outcome Measures

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

  Through study completion, an average of 6 months

Secondary Outcomes (1)

• Consistency Evaluation Between FeNO Analyzers

  through study completion, an average of 6 months

Other Outcomes (1)

• Cut-off of Tidal Breathing of FeNO

  through study completion, an average of 6 months

Study Arms (2)

Asthma Patients

OTHER

1. Individuals aged 18 years or older, regardless of gender; 2. Patients who have been diagnosed with bronchial asthma in accordance with the international GINA 2023 diagnostic criteria; 3. The presence of respiratory symptoms for a duration of no less than 6 weeks; 4. A history of non-smoking or cessation of smoking for a period exceeding 5 years.

Diagnostic Test: Chemiluminescent FeNO Analyzer; Diagnostic Test: Electrochemical FeNO Analyzer

Healthy

OTHER

1. Participants must be at least 18 years of age, regardless of gender; 2. There should be no documented history of allergic conditions or chronic respiratory illnesses, and no significant abnormalities should have been observed during physical examinations conducted in the preceding year; 3. Individuals must not have experienced any acute illnesses, should not have a history of medication use, and must not exhibit typical symptoms of respiratory infections within the last four weeks; 4. Participants must either have no history of smoking or must have ceased smoking for a duration exceeding five years.

Diagnostic Test: Chemiluminescent FeNO Analyzer; Diagnostic Test: Electrochemical FeNO Analyzer

Interventions

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.

Also known as: eNOglow

Asthma Patients; Healthy

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.

Asthma Patients; Healthy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Any underlying medical or psychiatric conditions that, in the investigator's assessment, would render the individual unsuitable for participation in the study.
• Healthy:
• Participants must be at least 18 years of age, with no restrictions on gender;
• Individuals should not have a history of allergic diseases or chronic respiratory conditions, and must not exhibit any significant abnormalities in health assessments conducted within the past year;
• There should be no acute illnesses or medication history within the preceding four weeks, and participants must not display any typical symptoms of respiratory infections;
• A history of smoking is not permitted, or individuals must have ceased smoking for a minimum of five years.
• Individuals who are pregnant, breastfeeding, or currently experiencing menstruation;
• Those who have been on long-term medication;
• Participants involved in other clinical research studies;
• Any potential medical or psychological conditions that the researcher deems may render the subject unsuitable for participation in the study.

Sponsors & Collaborators

• Novlead Inc.: lead
• Ruijin Hospital: collaborator

Study Sites (2)

Ruijin Hospital

Shanghai, Shanghai Municipality, China

COMPLETED

Wuxi Xinwu District Xinrui Hospital

Wuxi, China

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Ailing Song

  Wuxi Branch of Ruijin Hospital (Xinrui Hospital of Xinwu Distric, Wuxi)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhou Fang

CONTACT

+86 15655595707; zhou.fang@novlead.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 28, 2025
• Study Start: September 12, 2024
• Primary Completion: May 30, 2025
• Study Completion: September 1, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

CN (2)