FeNO Detection in Asthma Diagnosis: A New Technology Approach

Launched by NOVLEAD INC. · Feb 25, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on studying a new test that measures nitric oxide in the breath (called FeNO) to help diagnose and manage bronchial asthma and other airway diseases. The FeNO test is important because it can indicate inflammation in the airways, which is a key factor in asthma. The trial is using a new, easy-to-use analyzer that allows patients to breathe normally during the test, making it suitable for those who might have difficulty following traditional breathing instructions, such as children or elderly patients.

To participate in the trial, individuals must be at least 18 years old and have a confirmed diagnosis of bronchial asthma for at least six weeks. They should not be currently using certain asthma medications or have recent respiratory infections. Healthy participants are also welcome, provided they have no history of respiratory diseases and meet other specific health criteria. Those who join the study can expect a simple and quick test that could help improve asthma diagnosis and treatment, ultimately leading to better management of their condition.

Gender

ALL

Eligibility criteria

• Patients:
• Inclusion Criteria:
• • 1. Participants must be a minimum of 18 years of age, irrespective of gender;
• • 2. Individuals must possess a diagnosis of bronchial asthma that aligns with the international GINA 2023 diagnostic criteria;
• • 3. Respiratory symptoms must have been evident for at least 6 weeks;
• • 4. Participants should either have no history of smoking or have discontinued smoking for a period exceeding 5 years.
• Exclusion Criteria:
• • 1. The concurrent use of additional asthma medications (such as glucocorticoids) alongside short-acting bronchodilators within the prior 4 weeks;
• • 2. A diagnosis of respiratory infection within the preceding 4 weeks;
• • 3. Conditions such as pregnancy, lactation, or menstruation;
• • 4. Participation in other clinical research studies;
• • 5. Any underlying medical or psychiatric conditions that, in the investigator's assessment, would render the individual unsuitable for participation in the study.
• Healthy:
• Inclusion Criteria:
• • 1. Participants must be at least 18 years of age, with no restrictions on gender;
• • 2. 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;
• • 3. 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;
• • 4. A history of smoking is not permitted, or individuals must have ceased smoking for a minimum of five years.
• Exclusion Criteria:
• • 1. Individuals who are pregnant, breastfeeding, or currently experiencing menstruation;
• • 2. Those who have been on long-term medication;
• • 3. Participants involved in other clinical research studies;
• • 4. Any potential medical or psychological conditions that the researcher deems may render the subject unsuitable for participation in the study.