Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06852911

FeNO Detection in Asthma Diagnosis: A New Technology Approach

Led by Novlead Inc. · Updated on 2025-02-28

170

Participants Needed

2

Research Sites

50 weeks

Total Duration

On this page

Sponsors

N

Novlead Inc.

Lead Sponsor

R

Ruijin Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

FeNO Detection in Asthma Diagnosis: A New Technology Approach

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be 18 years or older.
  • Diagnosis of bronchial asthma according to international GINA 2023 criteria.
  • Respiratory symptoms present for at least 6 weeks.
  • No history of smoking or stopped smoking for more than 5 years.
  • For healthy individuals: no history of allergic or chronic respiratory diseases.
  • Healthy participants must have no acute illness or medication use in the past 4 weeks.
  • Healthy participants must have no significant abnormalities in health assessments within the past year.
Not Eligible

You will not qualify if you...

  • Use of asthma medications including glucocorticoids within the previous 4 weeks.
  • Diagnosis of respiratory infection within the last 4 weeks.
  • Pregnancy, breastfeeding, or menstruation.
  • Participation in other clinical studies.
  • Any medical or psychiatric condition judged by the investigator to make participation unsuitable.
  • For healthy individuals: long-term medication use.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Completed

2

Wuxi Xinwu District Xinrui Hospital

Wuxi, China

Actively Recruiting

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Research Team

Z

Zhou Fang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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