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Trial registered on ANZCTR
Registration number
ACTRN12618001832268
Ethics application status
Approved
Date submitted
2/11/2018
Date registered
9/11/2018
Date last updated
9/11/2018
Date data sharing statement initially provided
9/11/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Stratifying asthma severity in children using cough sound analytic technology.
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Scientific title
Stratifying asthma severity in children using cough sound analytic technology.
A sub-study of the Breathe Easy Study: Developing digital diagnostic tests for respiratory diseases using non-contact sound recordings in children and adults.
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Secondary ID [1]
296390
0
None
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Universal Trial Number (UTN)
U1111-1223-1911
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Trial acronym
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Linked study record
This study is a substudy (using the same cohort) of ACTRN12618001521213. The initial Breathe Easy study had diagnostic endpoints where this study is concerned with the severity of a known disease (asthma).
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Health condition
Health condition(s) or problem(s) studied:
Asthma
310281
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Condition category
Condition code
Respiratory
309018
309018
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0
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
We use the collected data and cough recordings obtained in the Breathe Easy Study (ACTRN12618001521213). This dataset consists of a training set with coupled cough recordings, clinical data and single adjudicator diagnostic evaluation and a testing set with cough recordings, clinical data and a consensus panel adjudicator diagnostic evaluation.
Phase 1 of the trial is to use the training set to develop the mathematical models to predict asthma severity using well known commonly used clinical scales (eg Pulmonary Score).
Phase 2 of the trial is to use the testing set to perform a diagnostic accuracy study.
The Breathe Easy protocol requires patients with defined respiratory conditions (including Asthma, COPD, Bronchiolitis, Croup, Interstitial Lung Disease, Pneumonia, Upper and Lower Respiratory infections, Bronchiectasis, Emphysema), confirmed by expert review, to provide one series of (5-10) coughs, recorded by a smartphone for analysis and technical development of an algorithm to produce a digital diagnostic test. This procedure takes 30 seconds when the patient can provide a voluntary cough and up to 5 minutes if spontaneous. Children (who are able to cough on demand or are doing so spontaneously) and adults will be approached by a trained research nurse.
The recordings are collected at two Perth hospitals in the emergency department, inpatient wards and ambulatory care settings.
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Intervention code [1]
312818
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Diagnosis / Prognosis
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Comparator / control treatment
The Pulmonary Score (Smith, S.R., et al.2002) will be used as the standard to develop the asthma severity score. This scoring system is the current standard in the two recruitment sites. In the testing phase, we will use the pulmonary score amongst other widely used scores including RAD (Arnold)
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Asthma severity as assessed by asthma severity scales including the Pulmonary Score (Smith, SR, et al 2002) and RAD (Arnold).
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Timepoint [1]
307972
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Severity calculations will occur simultaneously.
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Secondary outcome [1]
353543
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Asthma severity as assessed by test algorithm
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Timepoint [1]
353543
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Severity calculations will occur simultaneously.
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Eligibility
Key inclusion criteria
Clinical diagnosis of asthma.
As a substudy of the Breathe Easy study, the cohort has already been screened for the criteria below.
1. Patients with a history of a chronic respiratory condition or who have symptoms of an acute respiratory disease.
2. Patients without acute respiratory disease, with and without a history of asthma.
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Minimum age
10
Months
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Maximum age
No limit
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Gender
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
As a substudy of the Breathe Easy study, the cohort has already been screened for the criteria below.
Inability to Provide a cough either spontaneously or voluntarily.
Unable to provide informed consent or assent
Severe respiratory distress including the use of CPAP or BiPAP
Abdominal or eye surgery within 3 months
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The Breathe Easy study used a convenience sample. From the Study two groups were developed. One for training and one for testing. The training group data will be handled by the algorithm development team and the testing group by a separate analysis team.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint(s)
Efficacy
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Statistical methods / analysis
The PPA, PNA, LR+ and -, PPV and NPV with 95% confidence intervals between Pulmonary Score and the calculated cough severity score. Further age grouping 0-2 years, 2-12 years and adult as well as all age (children)
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
23/03/2015
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Date of last participant enrolment
Anticipated
31/12/2021
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Actual
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Date of last data collection
Anticipated
31/12/2021
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Actual
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Sample size
Target
500
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Accrual to date
400
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Joondalup Health Campus - Joondalup
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Recruitment hospital [2]
12344
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Perth Children's Hospital - Nedlands
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Recruitment postcode(s) [1]
24584
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6027 - Joondalup
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Recruitment postcode(s) [2]
24585
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6009 - Nedlands
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Funding & Sponsors
Funding source category [1]
300995
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Hospital
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Name [1]
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Joondalup Health Campus
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Address [1]
300995
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Grand Blvd &, Shenton Ave, Joondalup WA 6027
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Country [1]
300995
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Australia
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Funding source category [2]
301088
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Commercial sector/Industry
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Name [2]
301088
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ResApp Health
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Address [2]
301088
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44 St Georges Terrace, Perth WA 6000
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Country [2]
301088
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Australia
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Primary sponsor type
Individual
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Name
Paul Porter
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Address
Joondalup Health Campus
Grand Blvd &, Shenton Ave, Joondalup WA 6027
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Country
Australia
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Secondary sponsor category [1]
300582
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None
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Name [1]
300582
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Address [1]
300582
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Country [1]
300582
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301755
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Joondalup Health Campus Human Research Ethics Committee
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Ethics committee address [1]
301755
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Grand Blvd &, Shenton Ave, Joondalup WA 6027
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Ethics committee country [1]
301755
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Australia
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Date submitted for ethics approval [1]
301755
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29/01/2015
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Approval date [1]
301755
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06/03/2015
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Ethics approval number [1]
301755
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1501
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Summary
Brief summary
This study is designed to develop an accurate digital diagnostic test, used on a smart device, to measure the severity of asthma. These tests can then be used in resource-poor communities, emergency departments or via telehealth applications. The test would improve asthma action plans, a mainstay of asthma management.
The aim is to develop tests that are as accurate as an expert clinical assessment but do not need a clinical examination or other interventions such as bronchodilator (Ventolin) tests.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Paul Porter
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Address
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Suite 204
Medical Centre
Joondalup Health Campus
Grand Blvd &, Shenton Ave,
Joondalup WA 6027
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Country
87990
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Australia
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Phone
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+61 8 9400 9919
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Fax
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+61 8 9400 9909
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Email
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paul.porter@curtin.edu.au
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Contact person for public queries
Name
87991
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A/Prof Paul Porter
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Address
87991
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Suite 204
Medical Centre
Joondalup Health Campus
Grand Blvd &, Shenton Ave,
Joondalup WA 6027
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Country
87991
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Australia
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Phone
87991
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+61 8 94009919
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Fax
87991
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+61 8 9400 9909
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Email
87991
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paul.porter@curtin.edu.au
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Contact person for scientific queries
Name
87992
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A/Prof Paul Porter
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Address
87992
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Suite 204
Medical Centre
Joondalup Health Campus
Grand Blvd &, Shenton Ave,
Joondalup WA 6027
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Country
87992
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Australia
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Phone
87992
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+61 8 94009919
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Fax
87992
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+61 8 9400 9909
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Email
87992
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paul.porter@curtin.edu.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
The cough recordings and mathematical analysis techniques and development are subject to Intellectual property restrictions. We will release the cough recordings as a training tool in the future.
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What supporting documents are/will be available?
No other documents available
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Summary results
No Results
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