Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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.
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.
Secondary ID [1] 296390 0
None
Universal Trial Number (UTN)
U1111-1223-1911
Trial acronym
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).

Health condition
Health condition(s) or problem(s) studied:
Asthma 310281 0
Condition category
Condition code
Respiratory 309018 309018 0 0
Asthma

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 312818 0
Diagnosis / Prognosis
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)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307972 0
Asthma severity as assessed by asthma severity scales including the Pulmonary Score (Smith, SR, et al 2002) and RAD (Arnold).
Timepoint [1] 307972 0
Severity calculations will occur simultaneously.
Secondary outcome [1] 353543 0
Asthma severity as assessed by test algorithm
Timepoint [1] 353543 0
Severity calculations will occur simultaneously.

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.
Minimum age
10 Months
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

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)
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/03/2015
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
500
Accrual to date
400
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 12343 0
Joondalup Health Campus - Joondalup
Recruitment hospital [2] 12344 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 24584 0
6027 - Joondalup
Recruitment postcode(s) [2] 24585 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 300995 0
Hospital
Name [1] 300995 0
Joondalup Health Campus
Address [1] 300995 0
Grand Blvd &, Shenton Ave, Joondalup WA 6027
Country [1] 300995 0
Australia
Funding source category [2] 301088 0
Commercial sector/Industry
Name [2] 301088 0
ResApp Health
Address [2] 301088 0
44 St Georges Terrace, Perth WA 6000
Country [2] 301088 0
Australia
Primary sponsor type
Individual
Name
Paul Porter
Address
Joondalup Health Campus
Grand Blvd &, Shenton Ave, Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 300582 0
None
Name [1] 300582 0
Address [1] 300582 0
Country [1] 300582 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301755 0
Joondalup Health Campus Human Research Ethics Committee
Ethics committee address [1] 301755 0
Grand Blvd &, Shenton Ave, Joondalup WA 6027
Ethics committee country [1] 301755 0
Australia
Date submitted for ethics approval [1] 301755 0
29/01/2015
Approval date [1] 301755 0
06/03/2015
Ethics approval number [1] 301755 0
1501

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87990 0
A/Prof Paul Porter
Address 87990 0
Suite 204
Medical Centre
Joondalup Health Campus
Grand Blvd &, Shenton Ave,
Joondalup WA 6027
Country 87990 0
Australia
Phone 87990 0
+61 8 9400 9919
Fax 87990 0
+61 8 9400 9909
Email 87990 0
paul.porter@curtin.edu.au
Contact person for public queries
Name 87991 0
A/Prof Paul Porter
Address 87991 0
Suite 204
Medical Centre
Joondalup Health Campus
Grand Blvd &, Shenton Ave,
Joondalup WA 6027
Country 87991 0
Australia
Phone 87991 0
+61 8 94009919
Fax 87991 0
+61 8 9400 9909
Email 87991 0
paul.porter@curtin.edu.au
Contact person for scientific queries
Name 87992 0
A/Prof Paul Porter
Address 87992 0
Suite 204
Medical Centre
Joondalup Health Campus
Grand Blvd &, Shenton Ave,
Joondalup WA 6027
Country 87992 0
Australia
Phone 87992 0
+61 8 94009919
Fax 87992 0
+61 8 9400 9909
Email 87992 0
paul.porter@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.
What supporting documents are/will be available?
No other documents available
Summary results
No Results