Clinical trial NCT06661252: Evaluation of Nasal Biomarkers for Objective Assessment of Disease Severity in Respiratory Disorders
Official title: Evaluation of Nasal Biomarkers for Objective Assessment of Disease Severity in Respiratory Disorders
Study type: OBSERVATIONAL
Overall status: 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
Keywords: Nasal biomarker
Nasal fluid
Asthma biomarker
COPD biomarker
Rhinitis biomarker
Chronic sinusitis biomarker
Allergy
Respiratory disease
Lead sponsor: Diag-Nose Medical Pty Ltd
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Nasal biomarker discovery
timeFrame: From participant enrollment to the end of the site visit (up to a maximum of 26 weeks)
Secondary outcomes:
measure: ABEL microsampler validation
timeFrame: 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).
Other outcomes:
Locations:
city: Notting Hill
country: Australia
facility: Diag-Nose Medical
state: Victoria
Study officials:
References: