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

Diag-Nose Medical Pty Ltd

Status: Enrolling

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

Treatments: Device: ABEL microsampler device

Study type: Observational

Funder types: Other

Identifiers

NCT06661252

DNM_002_V240930

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

250 participants in 5 patient groups

Healthy Controls

Description:

Healthy volunteers.

Treatment:

Device: ABEL microsampler device

COPD sufferers

Description:

Previously diagnosed COPD sufferers.

Treatment:

Device: ABEL microsampler device

Asthma sufferers

Description:

Previously diagnosed asthma sufferers of various subtypes.

Treatment:

Device: ABEL microsampler device

Allergic rhinitis sufferers

Description:

Previously diagnosed seasonal or perennial allergic rhinitis sufferers.

Treatment:

Device: ABEL microsampler device

Chronic sinusitis sufferers

Description:

Previously diagnosed chronic sinusitis sufferers with/without nasal polyps.

Treatment:

Device: ABEL microsampler device