Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000977370
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
7/07/2026
Date registered
Help: Date registered
10/08/2026
Date last updated
Help: Date last updated
10/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
10/08/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Nasal Biomarkers for Objective Assessment of disease severity in Respiratory Disorders – Extended for Multiple Sites
Scientific title
Evaluation of Nasal Biomarkers for Objective Assessment of disease severity in Respiratory Disorders – Extended for Multiple Sites
Additional trial identifiers [1] 317815 0
DNM_002B_V260319
Universal Trial Number (UTN)
Trial acronym
ENBOARD-EMS
Related trial records
NCT06661252 - follow-up study.

Health condition
Health condition(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 342731 0
Asthma 342732 0
Rhinitis Allergic 342736 0
Non-allergic Rhinitis 342738 0
Chronic Sinusitis With or Without Nasal Polyps 342739 0
Condition category
Condition code
Respiratory 338867 338867 0 0
Chronic obstructive pulmonary disease
Respiratory 338868 338868 0 0
Asthma
Respiratory 338869 338869 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 338870 338870 0 0
Allergies
Inflammatory and Immune System 338871 338871 0 0
Other inflammatory or immune system disorders
Infection 338872 338872 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of the intervention or exposure
Treatment: Devices - ABEL microsampler device

The ABEL microsampler device is a nasal fluid sampling device that is intended for use in the context of research only. It is used to ensure standardised, high-quality nasal fluid collection and is not expected to result in direct clinical benefit to participants.

The ABEL microsampler device will be inserted in the nose of participants to collect nasal fluid samples for biomarker analysis at participating clinical sites. Nasal fluid samples will be collected by member of the clinical research team from each nostril of the participant, with the potential of obtaining up to three samples per nostril. The ABEL microsampler will be inserted into the nostril for approximately 2 minutes per sample.

Exposure groups:
COPD sufferers - Previously diagnosed COPD sufferers.
Asthma sufferers - Previously diagnosed asthma sufferers of various subtypes.
Allergic rhinitis sufferers - Previously diagnosed seasonal or perennial allergic rhinitis sufferers.
Chronic sinusitis sufferers - Previously diagnosed chronic sinusitis sufferers with/without nasal polyps.

Participants will be asked to complete: Sino-Nasal Outcome Test (SNOT-22), Total Nasal Symptom Score (TNSS), Asthma Control Questionnaire (ACQ-5), Asthma Quality of Life Questionnaire (AQLQ(S)), Eustachian Tube Dysfunction Questionnaire (ETDQ-7), Headache Impact Test (HIT-6), Reflux Symptom Index (RSI), St. George's Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT) which will take 30 minutes. Participants will also be required to complete a visual-analogue scale (for subjective symptom evaluation) as well as a range of clinical assessments (QoL, symptom assessment, clinical history, etc.) and respiratory function tests. These include spirometry, fractional exhaled nitric oxide and complete blood count analysis, which will take 1 hour.
Intervention code [1] 334654 0
Diagnosis / Prognosis
Description of the comparator or control
Control group - Healthy Volunteers

Treatment device (ABEL microsampler device) will be delivered at participating clinical sites.
Control group
Active

Outcomes
Primary outcome [1] 346084 0
Nasal Molecular Biomarkers (this will be assessed as a composite and exploratory outcome)
Timepoint [1] 346084 0
Nasal molecular biomarkers will be assessed following the nasal fluid collection during the single study visit.
Primary outcome [2] 346237 0
Quality of Life (this will be assessed as a composite outcome)
Timepoint [2] 346237 0
The quality of life outcome will be assessed during the single study visit.
Primary outcome [3] 346238 0
Accuracy of the developed machine learning algorithm in developing an objective biomarker-based disease severity score
Timepoint [3] 346238 0
The accuracy of the developed machine learning algorithm is assessed during and following the single study visit.
Secondary outcome [1] 464520 0
ABEL microsampler validation
Timepoint [1] 464520 0
For the duration of the study site visit (2 hour site visit) 5 minutes are allocated for tolerability and performance questionnaire.

Eligibility
Key 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.
* Participants must not be actively taking medications to treat any sinonasal or pulmonary condition at the time of enrolment.

Case goup:
* Participants must be previously diagnosed with rhinitis, chronic sinusitis, asthma, or COPD by a medical professional.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/05/2026
Date of last participant enrolment
Anticipated
1/11/2028
Actual
Date of last data collection
Anticipated
1/11/2028
Actual
Sample size
Target
1500
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC

Funding & Sponsors
Funding source category [1] 322358 0
Government body
Name [1] 322358 0
Cooperative Research Centres Projects (CRC-P) Grant funded by the Australian Government (Department of Industry, Science and Resources)
Country [1] 322358 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Diag-Nose Medical Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 325278 0
None
Name [1] 325278 0
Address [1] 325278 0
Country [1] 325278 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320861 0
Bellberry Human Research Ethics Committee J
Ethics committee address [1] 320861 0
Ethics committee country [1] 320861 0
Australia
Date submitted for ethics approval [1] 320861 0
30/07/2025
Approval date [1] 320861 0
08/10/2025
Ethics approval number [1] 320861 0
2025-07-1216-A-3

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 151866 0
A/Prof Joanne Rimmer
Address 151866 0
The ENT Clinic, 101 Bay Street, Brighton, Vic, 3186
Country 151866 0
Australia
Phone 151866 0
+61 4 0293 1120
Fax 151866 0
Email 151866 0
[email protected]
Contact person for public queries
Name 151867 0
Esrin Aydin
Address 151867 0
Diag-nose Medical Pty Ltd, Level 2, 1 Acacia Place Notting Hill Victoria 3168
Country 151867 0
Australia
Phone 151867 0
+61 4 5210 9882
Fax 151867 0
Email 151867 0
[email protected]
Contact person for scientific queries
Name 151868 0
Tanya Lupancu
Address 151868 0
Diag-nose Medical Pty Ltd, Level 2, 1 Acacia Place Notting Hill Victoria 3168
Country 151868 0
Australia
Phone 151868 0
+61 4 1915 1269
Fax 151868 0
Email 151868 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Undecided



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.