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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Controls | Healthy volunteers. |
| |
| COPD sufferers | Previously diagnosed COPD sufferers. |
| |
| Asthma sufferers | Previously diagnosed asthma sufferers of various subtypes. |
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| Allergic rhinitis sufferers | Previously diagnosed seasonal or perennial allergic rhinitis sufferers. |
| |
| Chronic sinusitis sufferers | Previously diagnosed chronic sinusitis sufferers with/without nasal polyps. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABEL microsampler device | Device | The ABEL microsampler device will be used to collect nasal fluid samples for biomarker analysis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nasal biomarker discovery | 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. | From participant enrollment to the end of the site visit (up to a maximum of 26 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| ABEL microsampler validation | 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. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diag-Nose Medical | Notting Hill | Victoria | 3168 | Australia |
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| Label | URL |
|---|---|
| Sponsor website | View source |
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Nasal fluid samples will be collected using the ABEL microsampler device.
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| D012220 | Rhinitis |
| D012221 | Rhinitis, Allergic, Perennial |
| D003139 | Common Cold |
| D006967 | Hypersensitivity |
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D065631 | Rhinitis, Allergic |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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