Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06852911

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

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

170

Participants Needed

2

Research Sites

13 weeks

Total Duration

On this page

Sponsors

N

Novlead Inc.

Lead Sponsor

R

Ruijin Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying a new method for detecting exhaled nitric oxide (FeNO) in the airways, which is important for identifying airway inflammation related to bronchial asthma and other respiratory conditions. This study explores a novel domestic chemiluminescence FeNO analyzer in China that measures FeNO during natural breathing without requiring patient cooperation. This technology aims to improve diagnosis and management for patients who cannot perform standard breathing tests, such as children, elderly, and seriously ill individuals. The study involves two groups: adults diagnosed with bronchial asthma following international criteria and healthy adults without respiratory or allergic diseases. Both groups undergo FeNO testing using two types of analyzers: the new chemiluminescence method and the commonly used electrochemical method. Each participant completes three test sessions per method, with the order randomized, following specific pre-test preparation rules involving medication and activity restrictions. Participants provide demographic and health information and follow pre-test guidelines including medication abstinence and fasting. Testing is conducted during daytime with rest intervals between repeated measurements. Researchers assess the performance of the new analyzer and compare results between the two devices over approximately six months. The goal is to evaluate the consistency and accuracy of this new FeNO detection technology to support better asthma and airway disease diagnosis.

CONDITIONS

Brief 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 at least 18 years old, regardless of gender
  • Diagnosis of bronchial asthma according to international GINA 2023 criteria
  • Respiratory symptoms present for at least 6 weeks
  • No history of smoking or smoking cessation for more than 5 years
  • Healthy individuals must be at least 18 years old with no allergic or chronic respiratory diseases
  • Healthy participants must have no acute illnesses or medication use in the past 4 weeks
  • Healthy participants must have no smoking history or stopped smoking over 5 years ago
Not Eligible

You will not qualify if you...

  • Use of asthma medications like glucocorticoids or short-acting bronchodilators within the past 4 weeks
  • Respiratory infection within the last 4 weeks
  • Pregnancy, breastfeeding, or menstruation
  • Participation in other clinical studies
  • Any medical or psychiatric conditions deemed unsuitable by investigators
  • Long-term medication use in healthy participants

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Approximately 20 minutes per participant

Participants undergo diagnostic testing using two different FeNO analyzers to assess exhaled nitric oxide levels in accordance with standardized technical guidelines.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 6 months

Participants are monitored to evaluate the performance and consistency of the FeNO analyzers over time.

Follow-up assessments as needed over 6 months

Trial Site Locations

Total: 2 locations

1

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Completed

2

Wuxi Xinwu District Xinrui Hospital

Wuxi, China

Actively Recruiting

Loading map...

Research Team

Z

Zhou Fang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

Similar Trials

Study of Asthma Step-up in Real Life (SURFE)

Bronchial Asthma

Actively Recruiting

1 location

Additive Effects of Alternative Nostril Breathing with Pharm...

Bronchial Asthma

Actively Recruiting

1 location

Adherence to Inhaled Therapy in Patients With Chronic Obstru...

Chronic Obstructive Pulmonary Disease (COPD)

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here