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
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