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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Ruijin Hospital
COMPLETED
Shanghai
Wuxi Xinwu District Xinrui Hospital
RECRUITING
Wuxi
Contact Information
Primary
Zhou Fang
zhou.fang@novlead.com
+86 15655595707
Time Frame
Start Date: 2024-09-12
Estimated Completion Date: 2025-09-01
Participants
Target number of participants: 170
Treatments
Other: Asthma Patients
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.
Other: Healthy
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.
Sponsors
Collaborators: Ruijin Hospital
Leads: Novlead Inc.

This content was sourced from clinicaltrials.gov

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