Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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
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