Evaluation of Nasal Biomarkers for Objective Assessment of Disease Severity in Respiratory Disorders (NCT06661252) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Nasal Biomarkers for Objective Assessment of Disease Severity in Respiratory Disorders
Australia111 participantsStarted 2025-01-08
Plain-language summary
This research study is an observational, single site study quantifying expression of biomarkers of respiratory disease in nasal fluid using the ABEL microsampler device. The primary objective of this study is to compare biomarker expression between healthy controls and participants with respiratory disorders such as chronic obstructive pulmonary disorder (COPD), hayfever, chronic sinusitis, asthma and rhinitis.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Nasal biomarker discovery
Timeframe: From participant enrollment to the end of the site visit (up to a maximum of 26 weeks)