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CompletedNCT06661252ENBOARDUpdated Apr 13, 2026

Evaluation of Nasal Biomarkers for Objective Assessment of Disease Severity in Respiratory Disorders

An observational study in Chronic Obstructive Pulmonary Disease (COPD), Asthma Patients and Asthma and Rhinitis, sponsored by Diag-Nose Medical Pty Ltd. Completed at 1 site in Australia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Diag-Nose Medical Pty Ltd · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
111
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Chronic Obstructive Pulmonary Disease (COPD)
  • Asthma Patients
  • Asthma and Rhinitis
  • Asthmatic Patients
  • Asthma, Chronic Obstructive Pulmonary Disease (COPD)
  • Rhinitis Allergic
  • Rhinitis, Allergic, Perennial and/or Seasonal
  • Non-allergic Rhinitis
  • Chronic Sinusitis With or Without Nasal Polyps
  • Healthy Volunteers

Keywords

  • Nasal biomarker
  • Nasal fluid
  • Asthma biomarker
  • COPD biomarker
  • Rhinitis biomarker
  • Chronic sinusitis biomarker
  • Allergy
  • Respiratory disease
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In context

Pulmonary Disease, Chronic Obstructive

5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.

This study's enrollment of 111 is below the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

This is the only study on the registry with Diag-Nose Medical Pty Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All participants:
  • 18 years of age or older
  • The participant must be able to comprehend and sign an approved 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 by a medical professional.

Exclusion criteria

Exclusion Criteria:

  • Less than 18 years of age at the time of enrolment.
  • Volunteers who are actively pregnant
  • Prior history of adverse reaction or 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
111 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Healthy Controls

    Healthy volunteers.

    Device: ABEL microsampler device

  • COPD sufferers

    Previously diagnosed COPD sufferers.

    Device: ABEL microsampler device

  • Asthma sufferers

    Previously diagnosed asthma sufferers of various subtypes.

    Device: ABEL microsampler device

  • Allergic rhinitis sufferers

    Previously diagnosed seasonal or perennial allergic rhinitis sufferers.

    Device: ABEL microsampler device

  • Chronic sinusitis sufferers

    Previously diagnosed chronic sinusitis sufferers with/without nasal polyps.

    Device: ABEL microsampler device

Interventions

  • DeviceABEL microsampler device

    The ABEL microsampler device will be used to collect nasal fluid samples for biomarker analysis.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    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).

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Study locations

1 site
  • Diag-Nose Medical
    Notting Hill, Victoria 3168, Australia
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References and documents

Related links

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2025 to primary completion in Nov 2025, 10 months.

Of 466 non-industry observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 64. This study's 10 months is below that.

Counting every sponsor, half of 586 studies reached it within 26 months; a quarter within 14 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2024
First posted
Oct 28, 2024
StartActual
Jan 8, 2025
Primary completionActual
Nov 25, 2025
CompletionActual
Nov 25, 2025
Last update
Apr 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06661252
Lead sponsor
Diag-Nose Medical Pty Ltd
Responsible party
Sponsor
First posted
Oct 28, 2024
Start date
Jan 8, 2025
Primary completion
Nov 25, 2025
Completion
Nov 25, 2025
Last update
Apr 13, 2026
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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