RecruitingNot ApplicableNCT06852911

FeNO Detection in Asthma Diagnosis: A New Technology Approach

The Diagnostic Significance of Exhaled Nitric Oxide (FeNO) With a Novel Technology in the Assessment of Bronchial Asthma


Sponsor

Novlead Inc.

Enrollment

170 participants

Start Date

Sep 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new handheld device to measure exhaled nitric oxide (a marker of airway inflammation) to help diagnose asthma more easily. It compares readings in people with asthma versus healthy volunteers. **You may be eligible if (asthma group):** - You are 18 years or older - You have been diagnosed with asthma according to standard guidelines - You have had breathing symptoms for at least 6 weeks - You are a non-smoker or have not smoked for more than 5 years **You may be eligible if (healthy volunteer group):** - You are 18 years or older - You have no history of allergic or chronic breathing conditions - You have not been sick or taken medication in the past 4 weeks **You may NOT be eligible if:** - You are pregnant, breastfeeding, or currently menstruating - You are on long-term medications - You are enrolled in another clinical study - You have recently had a respiratory infection (within 4 weeks) - You have recently used corticosteroid or bronchodilator medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTChemiluminescent 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_TESTElectrochemical 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.


Locations(2)

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Wuxi Xinwu District Xinrui Hospital

Wuxi, China

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NCT06852911


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