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

NCT06661252 | Completed

• 1 other identifier: DNM_002_V240930
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Nasal biomarker; Nasal fluid; Asthma biomarker; COPD biomarker; Rhinitis biomarker; Chronic sinusitis biomarker; Allergy; Respiratory disease

Outcome Measures

Primary Outcomes (1)

• Nasal biomarker discovery

  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 Outcomes (1)

• ABEL microsampler validation

  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).

Study Arms (5)

Healthy Controls

Healthy volunteers.

Device: ABEL microsampler device

COPD sufferers

Previously diagnosed COPD sufferers.

Device: ABEL microsampler device

Asthma sufferers

Previously diagnosed asthma sufferers of various subtypes.

Device: ABEL microsampler device

Allergic rhinitis sufferers

Previously diagnosed seasonal or perennial allergic rhinitis sufferers.

Device: ABEL microsampler device

Chronic sinusitis sufferers

Previously diagnosed chronic sinusitis sufferers with/without nasal polyps.

Device: ABEL microsampler device

Interventions

ABEL microsampler device DEVICE

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

Allergic rhinitis sufferers; Asthma sufferers; COPD sufferers; Chronic sinusitis sufferers; Healthy Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All participants:
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Diag-Nose Medical Pty Ltd: lead

Study Sites (1)

Diag-Nose Medical

Notting Hill, Victoria, 3168, Australia

Location

Related Links

• Sponsor website

Biospecimen

Retention: SAMPLES WITH DNA

Nasal fluid samples will be collected using the ABEL microsampler device.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Rhinitis; Rhinitis, Allergic, Perennial; Common Cold; Hypersensitivity; Respiration Disorders

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases; Respiratory Tract Infections; Infections; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis, Allergic; Picornaviridae Infections; RNA Virus Infections; Virus Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 28, 2024
• Study Start: January 8, 2025
• Primary Completion: November 25, 2025
• Study Completion: November 25, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

AU (1)