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RecruitingNCT06661252

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

Sponsor

Diag-Nose Medical Pty Ltd

Enrollment

250 participants

Start Date

Jan 8, 2025

Study Type

OBSERVATIONAL

Conditions

Healthy VolunteersChronic Obstructive Pulmonary Disease (COPD)Asthma PatientsRhinitis, AllergicAsthma and RhinitisAsthmatic PatientsAsthma, Chronic Obstructive Pulmonary Disease (COPD)Rhinitis, Allergic, Perennial and/or SeasonalNon-allergic RhinitisChronic Sinusitis With or Without Nasal Polyps

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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.

Exclusion Criteria6

  • 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

Interventions

DEVICEABEL microsampler device

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

Locations(1)

Diag-Nose Medical

Notting Hill, Victoria, Australia

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NCT06661252

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