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

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

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.

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