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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Asthma Asthma Patients Asthma and Rhinitis Asthma, Chronic Obstructive Pulmonary Disease (COPD) Asthmatic Patients Bronchial Diseases Chronic Disease Chronic Sinusitis With or Without Nasal Polyps Common Cold Disease Attributes Healthy Volunteers Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Non-allergic Rhinitis Nose Diseases Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Picornaviridae Infections Pulmonary Disease, Chronic Obstructive RNA Virus Infections Respiration Disorders Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinitis Allergic Rhinitis, Allergic Rhinitis, Allergic, Perennial Rhinitis, Allergic, Perennial and/or Seasonal Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Diag-Nose Medical

Notting Hill, Victoria, 3168, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABEL microsampler device

Device

The ABEL microsampler device will be used to collect nasal fluid samples for biomarker analysis.

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Diag-Nose Medical Pty Ltd

Other

Registry information

Acronym: ENBOARD

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Oct 28, 2024
Registry last updated: Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed