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

April 8, 2026 updated by: Diag-Nose Medical Pty Ltd
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Notting Hill, Victoria, Australia, 3168
        • Diag-Nose Medical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Any individual aged 18+, either as a healthy control or a medically diagnosed sufferer of hayfever, asthma, rhinitis, chronic rhinosinusitis or chronic obstructive pulmonary disorder.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Controls
Healthy volunteers.
Device: ABEL microsampler device
The ABEL microsampler device will be used to collect nasal fluid samples for biomarker analysis.
COPD sufferers
Previously diagnosed COPD sufferers.
Device: ABEL microsampler device
The ABEL microsampler device will be used to collect nasal fluid samples for biomarker analysis.
Asthma sufferers
Previously diagnosed asthma sufferers of various subtypes.
Device: ABEL microsampler device
The ABEL microsampler device will be used to collect nasal fluid samples for biomarker analysis.
Allergic rhinitis sufferers
Previously diagnosed seasonal or perennial allergic rhinitis sufferers.
Device: ABEL microsampler device
The ABEL microsampler device will be used to collect nasal fluid samples for biomarker analysis.
Chronic sinusitis sufferers
Previously diagnosed chronic sinusitis sufferers with/without nasal polyps.
Device: ABEL microsampler device
The ABEL microsampler device will be used to collect nasal fluid samples for biomarker analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal biomarker discovery
Time Frame: From participant enrollment to the end of the site visit (up to a maximum of 26 weeks)
To establish a correlation between nasal molecular biomarkers and disease severity and quality of life in patients with respiratory conditions (rhinitis, chronic sinusitis, asthma, COPD) compared to healthy controls, aiming to develop an objective biomarker-based disease severity score.
From participant enrollment to the end of the site visit (up to a maximum of 26 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ABEL microsampler validation
Time Frame: 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).
To validate the tolerability and performance of the ABEL nasal microsampling device in collecting nasal fluids from patients with respiratory conditions and healthy controls. This evaluation will focus on assessing the user comfort, the ease of administration and the consistency and precision of sample collection.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diag-Nose Medical Pty Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2025

Primary Completion (Actual)

November 25, 2025

Study Completion (Actual)

November 25, 2025

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DNM_002_V240930

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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