Asthma and Rhinitis, Asthma, Chronic Obstructive Pulmonary Disease (COPD), Asthma Patients, Asthmatic Patients, Chronic Obstructive Pulmonary Disease (COPD), Chronic Sinusitis With or Without Nasal Polyps, Healthy Volunteers, Non-allergic Rhinitis, Rhinitis Allergic, Rhinitis, Allergic, Perennial and/or Seasonal
Conditions
Keywords
Nasal biomarker, Nasal fluid, Asthma biomarker, COPD biomarker, Rhinitis biomarker, Chronic sinusitis biomarker, Allergy, Respiratory disease
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.
Interventions
DEVICEABEL microsampler device
The ABEL microsampler device will be used to collect nasal fluid samples for biomarker analysis.
Sponsors
Diag-Nose Medical Pty Ltd
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia
Outcome results
None listed