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NCT06661252 | RECRUITING | Chronic Obstructive Pulmonary Disease (COPD)

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

Condition or disease

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

Intervention/treatment

ABEL microsampler device

Study Type : OBSERVATIONAL
Estimated Enrollment : 250 participants
Official Title : Evaluation of Nasal Biomarkers for Objective Assessment of Disease Severity in Respiratory Disorders
Actual Study Start Date : 2025-01-08
Estimated Primary Completion Date : 2025-07
Estimated Study Completion Date : 2026-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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
Evaluation of Nasal Biomarkers for Objective Assessment of Disease Severity in Respiratory Disorders

Location Details

NCT06661252

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Australia, Victoria

Diag-Nose Medical

Notting Hill, Victoria, Australia, 3168