Evaluation of Nasal Biomarkers for Objective Assessment of Disease Severity in Respiratory Disorders

Launched by DIAG-NOSE MEDICAL PTY LTD · Oct 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how certain substances in nasal fluid, known as biomarkers, can help doctors understand the severity of respiratory diseases like asthma, chronic obstructive pulmonary disease (COPD), and sinusitis. Researchers will use a special device called the ABEL microsampler to collect nasal fluid from both healthy volunteers and patients with these respiratory conditions. By comparing the levels of these biomarkers between the two groups, the study aims to find out if they can provide useful information about the health of patients with respiratory disorders.

To participate in this study, you need to be at least 18 years old and able to understand and sign consent forms. Healthy volunteers should not have any significant nasal or lung symptoms, while participants in the case group must have a prior diagnosis of conditions like asthma or COPD. During the study, participants will provide nasal fluid samples, and those with certain medical histories or conditions may not be eligible. This research will help improve our understanding of respiratory diseases and could lead to better assessments and treatments in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * All participants:
• • 18 years of age or older
• • The participant must be able to comprehend and sign an approved Informed Consent Form and other applicable study documents.
• * Healthy volunteers:
• • No significant sinonasal/pulmonary symptoms or prior diagnoses of sinonasal/pulmonary conditions as determined by pre-enrolment questionnaires.
• * Case goup:
• • Participants must be previously diagnosed with rhinitis, chronic sinusitis, asthma, or COPD by a medical professional.
• Exclusion Criteria:
• • Less than 18 years of age at the time of enrolment.
• • Volunteers who are actively pregnant
• • Prior history of adverse reaction or contraindicated to diagnostic testing including fingerprick blood sampling, pulmonary testing, nasal swab/sampling.
• • Any other conditions limiting the volunteer's ability to complete study requirements in the judgement of the investigator/clinician
• • Any nasal anatomical issue or finding which may limit the safe insertion of the ABEL collection device, as determined by investigator/clinician
• • History of nasal surgery or trauma within the last 3 months