None listed
Conditions
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
Treatment: Devices - ABEL microsampler device
The ABEL microsampler device is a nasal fluid sampling device that is intended for use in the context of research only. It is used to ensure standardised, high-quality nasal fluid collection and is not expected to result in direct clinical benefit to participants.
The ABEL microsampler device will be inserted in the nose of participants to collect nasal fluid samples for biomarker analysis at participating clinical sites. Nasal fluid samples will b
Treatment: Devices - ABEL microsampler device The ABEL microsampler device is a nasal fluid sampling device that is intended for use in the context of research only. It is used to ensure standardised, high-quality nasal fluid collection and is not expected to result in direct clinical benefit to participants. The ABEL microsampler device will be inserted in the nose of participants to collect nasal fluid samples for biomarker analysis at participating clinical sites. Nasal fluid samples will be collected by member of the clinical research team from each nostril of the participant, with the potential of obtaining up to three samples per nostril. The ABEL microsampler will be inserted into the nostril for approximately 2 minutes per sample. Exposure groups: COPD sufferers - Previously diagnosed COPD sufferers. Asthma sufferers - Previously diagnosed asthma sufferers of various subtypes. Allergic rhinitis sufferers - Previously diagnosed seasonal or perennial allergic rhinitis sufferers. Chronic sinusitis sufferers - Previously diagnosed chronic sinusitis sufferers with/without nasal polyps. Participants will be asked to complete: Sino-Nasal Outcome Test (SNOT-22), Total Nasal Symptom Score (TNSS), Asthma Control Questionnaire (ACQ-5), Asthma Quality of Life Questionnaire (AQLQ(S)), Eustachian Tube Dysfunction Questionnaire (ETDQ-7), Headache Impact Test (HIT-6), Reflux Symptom Index (RSI), St. George's Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT) which will take 30 minutes. Participants will also be required to complete a visual-analogue scale (for subjective symptom evaluation) as well as a range of clinical assessments (QoL, symptom assessment, clinical history, etc.) and respiratory function tests. These include spirometry, fractional exhaled nitric oxide and complete blood count analysis, which will take 1 hour.
Sponsors
Diag-Nose Medical Pty Ltd
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. * Participants must not be actively taking medications to treat any sinonasal or pulmonary condition at the time of enrolment. 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
Outcome results
None listed