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

Recruiting

• Conditions: 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

• Registration Number: NCT06661252
• Lead Sponsor: Diag-Nose Medical Pty Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10
• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-10-24
• Last Update Submitted: 2024-10-24
• Study First Posted: 2024-10-28
• Last Update Posted: 2024-10-28
• Primary Completion: 2025-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nasal biomarker discovery	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 Outcome Measures

Name	Time	Method
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).	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.

Trial Locations

Locations (1)

Diag-Nose Medical; 🇦🇺 Port Melbourne, Victoria, Australia