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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06661252


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT06661252
Ethics application status
Date submitted
22/10/2024
Date registered
28/10/2024
Date last updated
28/10/2024

Titles & IDs
Public title
Evaluation of Nasal Biomarkers for Objective Assessment of Disease Severity in Respiratory Disorders
Scientific title
Evaluation of Nasal Biomarkers for Objective Assessment of Disease Severity in Respiratory Disorders
Secondary ID [1] 0 0
DNM_002_V240930
Universal Trial Number (UTN)
Trial acronym
ENBOARD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 0 0
Asthma Patients 0 0
Asthma and Rhinitis 0 0
Asthmatic Patients 0 0
Asthma, Chronic Obstructive Pulmonary Disease (COPD) 0 0
Rhinitis Allergic 0 0
Rhinitis, Allergic, Perennial And/or Seasonal 0 0
Non-allergic Rhinitis 0 0
Chronic Sinusitis with or Without Nasal Polyps 0 0
Healthy Volunteers 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Asthma
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - ABEL microsampler device

Healthy Controls - Healthy volunteers.

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.


Treatment: Devices: ABEL microsampler device
The ABEL microsampler device will be used to collect nasal fluid samples for biomarker analysis.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Nasal biomarker discovery
Timepoint [1] 0 0
From participant enrollment to the end of the site visit (up to a maximum of 26 weeks)
Secondary outcome [1] 0 0
ABEL microsampler validation
Timepoint [1] 0 0
For the duration of nasal fluid sample collection at the study site visit (2 hour site visit, with up to 20 minutes allocated for nasal fluid collection with breaks).

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.
* 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
Can healthy volunteers participate?
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
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Diag-Nose Medical - Port Melbourne
Recruitment postcode(s) [1] 0 0
3207 - Port Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Diag-Nose Medical Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT06661252
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Esrin Aydin
Address 0 0
Country 0 0
Phone 0 0
+61412898397
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06661252

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
VIC
Funding & Sponsors
Primary sponsor
Commercial sector/Industry
Primary sponsor name
Diag-Nose Medical Pty Ltd
Primary sponsor address
660 Lorimer St, Port Melbourne 3207
Primary sponsor country
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 83
Bellberry Limited
Address [1] 83
123 Glen Osmond Road Eastwood SA 5063
Country [1] 83
Australia
Date submitted for ethics approval [1] 83
11/09/2024
Approval date [1] 83
22/10/2024
Ethics approval number [1] 83
2024-08-1110
 
Public notes

Contacts
Principal investigator
Title 473 0
A/Prof
Name 473 0
Joanne Rimmer
Address 473 0
Country 473 0
Australia
Phone 473 0
Fax 473 0
Email 473 0
Contact person for public queries
Title 474 0
Dr
Name 474 0
Esrin Aydin
Address 474 0
Country 474 0
Australia
Phone 474 0
Fax 474 0
Email 474 0
[email protected]
Contact person for scientific queries
Title 475 0
Dr
Name 475 0
Esrin Aydin
Address 475 0
Country 475 0
Australia
Phone 475 0
Fax 475 0
Email 475 0
[email protected]