Evaluating nasal biomarkers for assessing respiratory disease severity
Evaluation of Nasal Biomarkers for Objective Assessment of Disease Severity in Respiratory Disorders
This study is testing if measuring certain substances in nasal fluid can help understand how severe respiratory diseases like COPD and asthma are, compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Diag-Nose Medical Pty Ltd Academic / other |
| Locations | 1 site (Port Melbourne, Victoria) |
| Trial ID | NCT06661252 on ClinicalTrials.gov |
What this trial studies
This observational study aims to quantify the expression of biomarkers in nasal fluid from participants with respiratory disorders, including COPD and asthma, using the ABEL microsampler device. It compares biomarker levels between healthy individuals and those diagnosed with conditions such as chronic sinusitis and rhinitis. The study focuses on understanding how these biomarkers correlate with disease severity and may help in objective assessments of respiratory conditions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of asthma, COPD, rhinitis, or chronic sinusitis.
Not a fit: Patients under 18, pregnant individuals, or those with significant sinonasal/pulmonary symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and objective assessments of respiratory diseases, improving patient management and treatment strategies.
How similar studies have performed: While the approach of using nasal biomarkers is promising, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Port Melbourne, Victoria
- Diag-Nose Medical — Port Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Esrin Aydin
- Email: eaydin@diag-nose.io
- Phone: +61412898397
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.