Chronic Obstructive Pulmonary Disease (COPD)ENBOARDNCT06661252
Evaluation of Nasal Biomarkers for Objective Assessment of Disease Severity in Respiratory Disorders
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Asthma Patients, run by Diag-Nose Medical Pty Ltd at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Asthma Patients, Asthma and Rhinitis
- What is being tested?
- ABEL microsampler device
- Type of treatment
- Medical device
- How many people
- 111 participants
- Where
- 1 siteAustralia
- Study dates
- 8 Jan 2025to 25 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Asthma Patients, Asthma and Rhinitis, Asthmatic Patients, Asthma, Chronic Obstructive Pulmonary Disease (COPD), Rhinitis Allergic
- Being tested
- ABEL microsampler device
- Keywords
- Nasal biomarker, Nasal fluid, Asthma biomarker, COPD biomarker, Rhinitis biomarker, Chronic sinusitis biomarker, Allergy, Respiratory disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Rhinitis, Rhinitis, Allergic, Perennial, Common Cold, Hypersensitivity, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABEL microsampler deviceDevice
The ABEL microsampler device will be used to collect nasal fluid samples for biomarker analysis.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Healthy volunteers. Receives: Device: ABEL microsampler device | |
| COPD sufferers | Previously diagnosed COPD sufferers. Receives: Device: ABEL microsampler device | |
| Asthma sufferers | Previously diagnosed asthma sufferers of various subtypes. Receives: Device: ABEL microsampler device | |
| Allergic rhinitis sufferers | Previously diagnosed seasonal or perennial allergic rhinitis sufferers. Receives: Device: ABEL microsampler device | |
| Chronic sinusitis sufferers | Previously diagnosed chronic sinusitis sufferers with/without nasal polyps. Receives: Device: ABEL microsampler device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From participant enrollment to the end of the site visit (up to a maximum of 26 weeks)
Secondary outcomes (1)
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start8 Jan 2025
- Primary completion25 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diag-Nose Medical Pty Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661252
- Sponsor's protocol ID
- DNM_002_V240930
- Acronym
- ENBOARD
- Status last verified
- Apr 2026
- First submitted
- 22 Oct 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nasal Biomarkers for Objective Assessment of Disease Severity in Respiratory Disorders
- ClinicalTrials.gov ID
- NCT06661252
- Acronym / sponsor ID
- ENBOARD / DNM_002_V240930
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Asthma Patients, Asthma and Rhinitis, Asthmatic Patients, Asthma, Chronic Obstructive Pulmonary Disease (COPD), Rhinitis Allergic
- Keywords
- Nasal biomarker, Nasal fluid, Asthma biomarker, COPD biomarker, Rhinitis biomarker, Chronic sinusitis biomarker, Allergy, Respiratory disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Diag-Nose Medical Pty LtdUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Device: ABEL microsampler deviceHealthy volunteers. |
| COPD sufferers | – | Device: ABEL microsampler devicePreviously diagnosed COPD sufferers. |
| Asthma sufferers | – | Device: ABEL microsampler devicePreviously diagnosed asthma sufferers of various subtypes. |
| Allergic rhinitis sufferers | – | Device: ABEL microsampler devicePreviously diagnosed seasonal or perennial allergic rhinitis sufferers. |
| Chronic sinusitis sufferers | – | Device: ABEL microsampler devicePreviously diagnosed chronic sinusitis sufferers with/without nasal polyps. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABEL microsampler deviceThe ABEL microsampler device will be used to collect nasal fluid samples for biomarker analysis. | Device | Allergic rhinitis sufferers, Asthma sufferers, COPD sufferers, Chronic sinusitis sufferers, Healthy Controls |
Primary outcome
Nasal biomarker discovery
Time frame: 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.
1 secondary outcome
ABEL microsampler validation
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Sponsor websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Asthma Patients, run by Diag-Nose Medical Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal biomarker discovery (time frame: From participant enrollment to the end of the site visit (up to a maximum of 26 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.