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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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