Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000902392
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
17/03/2026
Date registered
Help: Date registered
22/07/2026
Date last updated
Help: Date last updated
22/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
22/07/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Use of an electronic nose (SpiroNose®) to diagnose respiratory symptoms, lung abnormalities and sleep disorders.
Scientific title
Sensitivity and acceptability of the SpiroNose® device for diagnosing patients with respiratory symptoms or lung abnormalities or sleep disorders: a prospective multicentre study.
Additional trial identifiers [1] 316705 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The BARD study (Breath Analysis for Respiratory and sleep Diagnosis)
Related trial records

Health condition
Health condition(s) studied:
Asthma 340965 0
Chronic obstructive pulmonary disease 340966 0
Bronchiectasis 340967 0
Interstitial lung diseases (ILDs) 340968 0
Interstitial lung abnormalities (ILAs) 340969 0
Environmental lung disease 340970 0
Pleural diseases 340971 0
Lung cancer 340972 0
Pulmonary nodules 340973 0
Cardiac failure 340974 0
Vaping-associated pulmonary injury (EVALI) 340975 0
Narcolepsy 340976 0
Obstructive sleep apnoea (OSA) 340977 0
Condition category
Condition code
Respiratory 337110 337110 0 0
Asthma
Respiratory 337111 337111 0 0
Chronic obstructive pulmonary disease
Respiratory 337112 337112 0 0
Sleep apnoea
Respiratory 337118 337118 0 0
Other respiratory disorders / diseases
Cancer 337119 337119 0 0
Lung - Non small cell
Cancer 337121 337121 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention is an electronic nose called SpiroNose®. It is a breath analyser that participants breathe into for a few seconds to enable it to analyse patterns of chemicals called volatile organic compounds, which may differ between people with different medical conditions.

The SpiroNose® breath test is administered by an experienced study coordinator during a participant’s routine respiratory or sleep clinic visit. Participants breathe normally into the mouthpiece 5 times before filling the lungs, holding this for 5 seconds, then slowly breathing all the air out, followed finally by a deep breath before coming off the mouthpiece.

Participants complete a short questionnaire after the breath test to determine how acceptable they found the SpiroNose® breath test (ie how easy or difficult it was to perform). They also complete questionnaires about their health, including medical diagnoses, medications and symptoms. All questionnaires are de-identified.

Two months after the study visit, the study coordinator will contact participants by telephone to ask whether they have received a diagnosis, had any changes to their treatment or medications, and whether they have undergone any additional investigations. Relevant information may also be collected from participants' medical records from the time of the breath test up to 24 months later.

Participants attending the respiratory clinic for assessment or management of lung cancer may be invited by their treating physician to perform a second SpiroNose® breath test after surgery or treatment as part of their clinical care.
Intervention code [1] 333388 0
Diagnosis / Prognosis
Description of the comparator or control
The comparator is a group of about 50 adults in the community who are free from respiratory symptoms, lung abnormalities and sleep disorders, matched on age, sex and smoking status (never/ex/current).

These healthy controls will be invited to perform the SpiroNose® breath test in the same respiratory or sleep clinic as are clinic participants. While they are not required to complete disease-specific questionnaires, they will be asked to complete the 'acceptability' questionnaire to determine how they found the SpiroNose® breath test (ie how easy or difficult it was to perform).

As with clinic participants, healthy controls will be followed up 2 months after the breath test to determine if there has been a change in their health status. There will be no search through their medical records at any point in time given that these individuals reported being free from respiratory, lung and sleep disorders at screening.
Control group
Active

Outcomes
Primary outcome [1] 346121 0
Sensitivity of the SpiroNose® test for diagnosing health conditions causing respiratory symptoms, lung imaging abnormalities and sleep disorders.
Timepoint [1] 346121 0
At SpiroNose® breath test or up to 24 months later.
Primary outcome [2] 346122 0
Acceptability of the SpiroNose® test to patients in clinical practice.
Timepoint [2] 346122 0
Immediately after performing the SpiroNose® breath test.
Secondary outcome [1] 464676 0
[1] Specificity of SpiroNose® breathprints for identifying participants with specific health conditions.
Timepoint [1] 464676 0
At SpiroNose® breath test or up to 24 months later.
Secondary outcome [2] 464677 0
[2] Positive predictive value (PPV) of SpiroNose® breathprints.
Timepoint [2] 464677 0
At SpiroNose® breath test or up to 24 months later.
Secondary outcome [3] 464678 0
[3] Negative predictive value (NPV) of SpiroNose® breathprints.
Timepoint [3] 464678 0
At SpiroNose® breath test or up to 24 months later.
Secondary outcome [4] 464686 0
[4] Positive Likelihood Ratios of SpiroNose® breathprints.
Timepoint [4] 464686 0
At SpiroNose® breath test or up to 24 months later.
Secondary outcome [5] 464687 0
[5] Negative Likelihood Ratios of SpiroNose® breathprints.
Timepoint [5] 464687 0
At SpiroNose® breath test or up to 24 months later.
Secondary outcome [6] 464688 0
[6] Specificity of baseline SpiroNose® breathprints for non-response to lung cancer treatment.
Timepoint [6] 464688 0
Up to 24 months after the SpiroNose® breath test.
Secondary outcome [7] 464689 0
[7] Area under the curve (AUC) for SpiroNose® breathprints for distinguishing between patients with lung cancer who do, or do not, have various risk factors (including demographic, ancestry, smoking history).
Timepoint [7] 464689 0
Up to 24 months after the SpiroNose® breath test.
Secondary outcome [8] 464690 0
[8] AUC for SpiroNose® breathprints for distinguishing between subgroups of diseases (e.g. corticosteroid-sensitive vs corticosteroid-refractory asthma; subtypes of narcolepsy).
Timepoint [8] 464690 0
Up to 24 months after the SpiroNose® breath test.
Secondary outcome [9] 464691 0
[9] AUC for SpiroNose® breathprints for distinguishing participants with specific abnormalities on lung imaging from age-, sex- and smoking status-matched controls.
Timepoint [9] 464691 0
At SpiroNose® breath test or up to 24 months later.
Secondary outcome [10] 464692 0
[10] AUC for SpiroNose® breathprints for identifying responders and non-responders to specific medications in patients with severe asthma or COPD.
Timepoint [10] 464692 0
Up to 24 months after the SpiroNose® breath test.
Secondary outcome [11] 464693 0
[11] AUC for SpiroNose® breathprints for distinguishing participants with e-cigarette or vaping-associated lung injury (EVALI) from breathprints of people who have no history of vaping.
Timepoint [11] 464693 0
Up to 24 months after the SpiroNose® breath test.

Eligibility
Key inclusion criteria
Patients attending routine respiratory, sleep or lung assessment are potentially eligible if aged 18 years or over, are willing to provide written informed consent AND have any chronic respiratory or sleep symptoms (cough, wheeze, shortness of breath, chest tightness, haemoptysis) or diagnoses that may cause or contribute to respiratory symptoms (including but not limited to asthma, COPD, lung cancer, interstitial lung abnormalities, cardiac failure, obstructive sleep apnoea or narcolepsy) and/or have abnormalities on lung imaging.

Adults in the community may be eligible as controls if they are aged 18 years or over, provide written informed consent, and do not have any of the symptoms or conditions listed above.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Potential participants will be excluded from enrolment in the study if they have:
•Any condition that interferes with their ability to understand the study requirements.
•Any condition with a life expectancy of less than 6 months

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size: Previous studies which have tested the diagnostic accuracy of the SpiroNose® have shown that 50-60 participants with a specific clinical condition are needed to characterise its breathprint. This study plans to recruit 50-60 participants with each clinical condition and approximately 50 matched individuals free from respiratory, lung and sleep disorders to act as 'healthy' controls.

Statistical Analysis: Principle component analysis will be used with data from the SpiroNose® sensors to identify the elements that explain the most variation in the data between cases (participants with a specific diagnosis) and controls (participants without that diagnosis).

Where applicable:
1. Receiver Operating Characteristic (ROC) curves will be constructed by plotting sensitivity against the false positive rate (1 - specificity) across a range of SpiroNose® classification thresholds (cut-off values) for each condition studied.
2. Area Under the ROC Curve (AUC) will be calculated to evaluate the overall diagnostic performance of the SpiroNose® test in distinguishing participants with the condition from control participants without the condition.

AUC values closer to 1.0 indicate better diagnostic accuracy, while an AUC of 0.5 indicates performance no better than chance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2026
Actual
Date of last participant enrolment
Anticipated
15/08/2029
Actual
Date of last data collection
Anticipated
15/08/2031
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 321310 0
Government body
Name [1] 321310 0
NHMRC
Country [1] 321310 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Woolcock Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 324044 0
None
Name [1] 324044 0
Address [1] 324044 0
Country [1] 324044 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319842 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 319842 0
Ethics committee country [1] 319842 0
Australia
Date submitted for ethics approval [1] 319842 0
23/01/2026
Approval date [1] 319842 0
09/06/2026
Ethics approval number [1] 319842 0
X26-0022, PID00143 & 2026/ETH00119

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 148586 0
Prof Helen Reddel
Address 148586 0
The Woolcock Institute of Medical Research, 2 Innovation Road, Macquarie Park, NSW 2113
Country 148586 0
Australia
Phone 148586 0
+61 2 9805 3247
Fax 148586 0
Email 148586 0
[email protected]
Contact person for public queries
Name 148587 0
Gloria Foxley
Address 148587 0
The Woolcock Institute of Medical Research, 2 Innovation Road, Macquarie Park, NSW 2113
Country 148587 0
Australia
Phone 148587 0
+61 2 9805 3247
Fax 148587 0
Email 148587 0
[email protected]
Contact person for scientific queries
Name 148588 0
Helen Reddel
Address 148588 0
The Woolcock Institute of Medical Research, 2 Innovation Road, Macquarie Park, NSW 2113
Country 148588 0
Australia
Phone 148588 0
+61 2 9805 3247
Fax 148588 0
Email 148588 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.