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

NCT ID: NCT06661252

Last Updated: 2025-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-08

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD) Asthma Patients Asthma and Rhinitis Asthmatic Patients Asthma, Chronic Obstructive Pulmonary Disease (COPD) Rhinitis Allergic Rhinitis, Allergic, Perennial and/or Seasonal Non-allergic Rhinitis Chronic Sinusitis With or Without Nasal Polyps Healthy Volunteers

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Controls

Healthy volunteers.

ABEL microsampler device

Intervention Type DEVICE

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

COPD sufferers

Previously diagnosed COPD sufferers.

ABEL microsampler device

Intervention Type 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.

ABEL microsampler device

Intervention Type 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.

ABEL microsampler device

Intervention Type 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.

ABEL microsampler device

Intervention Type DEVICE

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

Interventions

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ABEL microsampler device

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Diag-Nose Medical Pty Ltd

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Diag-Nose Medical

Notting Hill, Victoria, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Esrin Aydin

Role: CONTACT

+61452109882

Eldin Rostom

Role: CONTACT

+61452109882

Facility Contacts

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Eldin Rostom

Role: primary

+61452109882

Esrin Aydin

Role: backup

+61452 109 882

Related Links

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https://diag-nose.io

Sponsor website

Other Identifiers

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DNM_002_V240930

Identifier Type: -

Identifier Source: org_study_id

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