Bronchial AsthmaNCT06852911
FeNO Detection in Asthma Diagnosis: A New Technology Approach
A study testing Chemiluminescent FeNO Analyzer and Electrochemical FeNO Analyzer in people with Bronchial Asthma and Airway Disease, run by Novlead Inc. at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bronchial Asthma, Airway Disease
- What is being tested?
- Chemiluminescent FeNO Analyzer and Electrochemical FeNO Analyzer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 2 sitesChina
- Study dates
- 12 Sep 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 1 recruiting
- Completed
Ruijin Hospital
Shanghai, Shanghai Municipality
- Recruiting
Wuxi Xinwu District Xinrui Hospital
Wuxi
Zhou Fang, +86 15655595707, zhou.fang@novlead.com
About this study
Official title: The Diagnostic Significance of Exhaled Nitric Oxide (FeNO) With a Novel Technology in the Assessment of Bronchial Asthma
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.
Read the detailed description
- Asthmatic patients and healthy individuals who fulfilled the inclusion criteria were categorized and assigned identification numbers.
- The basic demographic and health-related information of the subjects was documented, including age, sex, height, weight, respiratory symptoms, medical history, allergy history, disease diagnosis, comorbidities, medication history, smoking history, lung function test results, and other relevant examinations.
- Pre-testing requirements and preparations included:
- Abstaining from all medications (including glucocorticoids, type II inflammatory monoclonal antibodies, leukotriene receptor antagonists, antihistamines, decongestants, hypertonic saline, bronchoconstrictor/diastolic agents, NO synthase inhibitors, and NO donor drugs such as nitroglycerin or L-arginine) for a duration of six hours prior to the test;
- Fasting for three hours before the test;
- Avoiding all forms of liquid intake (including alcohol and coffee), smoking (both active and passive), strenuous physical activity (such as running or aerobic exercise), and any respiratory diagnostic or therapeutic procedures (including pulmonary function tests and aerosol inhalation) for one hour prior to the test.
- The researcher verified the subjects' compliance with the aforementioned testing requirements and proceeded with testing for those who met the criteria. Testing was uniformly scheduled during daytime hours.
- Each participant underwent testing using both the moisture method and the online method, with the order of tests determined randomly via a randomization table to mitigate potential sequential effects. Each test was conducted in accordance with the ATS/ERS Technical Standard for the Determination of Exhaled Nitric Oxide (2005) and the operational guidelines for the equipment. Subjects were instructed to maintain an upright position and to repeat each test three times while in a resting state. A resting period of at least 30 seconds was mandated between tests, provided the subjects experienced no discomfort. The total duration of the testing procedure was anticipated to be approximately 20 minutes per individual.
- Conditions
- Bronchial Asthma, Airway Disease
- Being tested
- Chemiluminescent FeNO Analyzer, Electrochemical FeNO Analyzer
- Keywords
- FeNO, Bronchial asthma, Tidal breathing
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemiluminescent FeNO AnalyzerDiagnostic test
Also called eNOglow
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.
Electrochemical FeNO AnalyzerDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Chemiluminescent FeNO Analyzer; Diagnostic Test: Electrochemical FeNO Analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 6 months
Secondary outcomes (1)
Consistency Evaluation Between FeNO Analyzers
Evaluation of the consistency between the chemiluminescence FeNO analyzer and the electrochemical FeNO analyzers, utilizing correlation and Bland-Altman analysis.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start12 Sep 2024
- Primary completion30 May 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novlead Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ruijin Hospital
- Responsible party
- Sponsor
- Investigators
- Ailing Song, Principal investigator, Wuxi Branch of Ruijin Hospital (Xinrui Hospital of Xinwu Distric, Wuxi)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852911
- Sponsor's protocol ID
- FeNO2403-1.3
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Significance of Exhaled Nitric Oxide (FeNO) With a Novel Technology in the Assessment of Bronchial Asthma
- ClinicalTrials.gov ID
- NCT06852911
- Acronym / sponsor ID
- FeNO2403-1.3
- Conditions
- Bronchial Asthma, Airway Disease
- Keywords
- FeNO, Bronchial asthma, Tidal breathing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Novlead Inc.Industry (pharma, biotech, devices)
- Collaborators
- Ruijin Hospital
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Asthmatic patients and healthy individuals who fulfilled the inclusion criteria were categorized and assigned identification numbers.
- The basic demographic and health-related information of the subjects was documented, including age, sex, height, weight, respiratory symptoms, medical history, allergy history, disease diagnosis, comorbidities, medication history, smoking history, lung function test results, and other relevant examinations.
- Pre-testing requirements and preparations included:
- Abstaining from all medications (including glucocorticoids, type II inflammatory monoclonal antibodies, leukotriene receptor antagonists, antihistamines, decongestants, hypertonic saline, bronchoconstrictor/diastolic agents, NO synthase inhibitors, and NO donor drugs such as nitroglycerin or L-arginine) for a duration of six hours prior to the test;
- Fasting for three hours before the test;
- Avoiding all forms of liquid intake (including alcohol and coffee), smoking (both active and passive), strenuous physical activity (such as running or aerobic exercise), and any respiratory diagnostic or therapeutic procedures (including pulmonary function tests and aerosol inhalation) for one hour prior to the test.
- The researcher verified the subjects' compliance with the aforementioned testing requirements and proceeded with testing for those who met the criteria. Testing was uniformly scheduled during daytime hours.
- Each participant underwent testing using both the moisture method and the online method, with the order of tests determined randomly via a randomization table to mitigate potential sequential effects. Each test was conducted in accordance with the ATS/ERS Technical Standard for the Determination of Exhaled Nitric Oxide (2005) and the operational guidelines for the equipment. Subjects were instructed to maintain an upright position and to repeat each test three times while in a resting state. A resting period of at least 30 seconds was mandated between tests, provided the subjects experienced no discomfort. The total duration of the testing procedure was anticipated to be approximately 20 minutes per individual.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma Patients | Other | Diagnostic Test: Chemiluminescent FeNO Analyzer, Diagnostic Test: Electrochemical FeNO Analyzer1. 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. |
| Healthy | Other | Diagnostic Test: Chemiluminescent FeNO Analyzer, Diagnostic Test: Electrochemical FeNO Analyzer1. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Participants must be at least 18 years of age, with no restrictions on gender;
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemiluminescent FeNO AnalyzerAlso: eNOglowA 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 test | Asthma Patients, Healthy |
| Electrochemical FeNO AnalyzerElectrochemical 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. | Diagnostic test | Asthma Patients, Healthy |
Primary outcome
Performance Assessment of FeNO Chemiluminescence Analyzer
Time frame: Through study completion, an average of 6 months
Assessment of the performance of the FeNO chemiluminescence analyzer, focusing on repeatability (coefficient of variation, CV), sensitivity, specificity, and receiver operating characteristic (ROC) curves
1 secondary outcome
Consistency Evaluation Between FeNO Analyzers
Time frame: through study completion, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ailing Song principal investigator
Wuxi Branch of Ruijin Hospital (Xinrui Hospital of Xinwu Distric, Wuxi)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemiluminescent FeNO Analyzer and Electrochemical FeNO Analyzer in people with Bronchial Asthma and Airway Disease, run by Novlead Inc. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhou Fang (+86 15655595707, zhou.fang@novlead.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Assessment of FeNO Chemiluminescence Analyzer (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.