Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000904673
Ethics application status
Approved
Date submitted
19/07/2023
Date registered
23/08/2023
Date last updated
24/03/2024
Date data sharing statement initially provided
23/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Paediatric Asthma and Wheeze Study - Part 1
Scientific title
Using a wheeze scan device (WheezeScan) for the management of preschool wheeze and paediatric asthma: a multicentre cohort study - Part 1
Secondary ID [1] 310386 0
None
Universal Trial Number (UTN)
Trial acronym
PAWS-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wheeze in pre-school children (Preschool Wheeze) 330737 0
Asthma 330924 0
Condition category
Condition code
Respiratory 327583 327583 0 0
Other respiratory disorders / diseases
Respiratory 327700 327700 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of WheezeScan (WzS), a portable user-friendly digital device that listens to 30sec of breathing then objectively documents wheeze using AI-informed signal processing. WzS is manufactured by Omron (Japan).

Parents will be trained by the research nurses/assistants using a standard protocol provided by the manufacturers (sse link https://www.omron-healthcare.co.uk/nebulisers/wheezescan.html). Adherence will be monitored using participant diaries. Wheezescan will be used at least once a day over the study period of 5 weeks.
Intervention code [1] 326556 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335415 0
Definite diagnosis (yes/no) of asthma classification assessed at T3 (6 weeks post T1) compared to T1 (baseline). Definite yes asthma’ is defined by the presence of reversible airway obstruction (disappearance of wheeze using WzS after 400ug SABA); ‘No’=no wheeze documented; ‘possible’=wheeze without clear response post-SABA or does not fit into ‘asthma’ or ‘no’ category.
Timepoint [1] 335415 0
6 weeks post baseline (T3)
Secondary outcome [1] 424450 0
Difference in a PedsQL4 (a health-related patient related outcome) between the timepoints (T3-T1, T3-T2).
Timepoint [1] 424450 0
Baseline (T1), 2 weeks post-baseline (T2) and 6 weeks post-baseline (T3).
Secondary outcome [2] 424451 0
Agreement of diagnosis using WzS and that classified by independent specialist paediatric respiratory physician after reviewing all available data. Concordance between the classification types. No classification of severity will be used as it is not applicable.
Timepoint [2] 424451 0
6weeks post baseline (T3).
Secondary outcome [3] 424452 0
Healthcare resource use collected from medical records and from participants using study-specific collection forms.
Timepoint [3] 424452 0
6 weeks post-baseline (T3)
Secondary outcome [4] 424453 0
Usefulness of WzS using Likert Scale (scored by parent)
Timepoint [4] 424453 0
6 weeks post-baseline (T3)
Secondary outcome [5] 424454 0
A composite outcome - Usefulness of WzS. It will be considered useful if (a) WzS assisted in a definite diagnosis (yes/no) or (b) patient-related outcomes (PROs) outcomes are superior in the WzS-based vs independent asthma classification groups and (c) did not incur (net) healthcare cost impacts. Each of the these are defined above.
Timepoint [5] 424454 0
6 weeks post-baseline (T3)
Secondary outcome [6] 424808 0
Difference in paediatric cough-specific quality-of-life (PC-QoL) scores in the subset who have cough for T3-T1 and T3-T2.
Timepoint [6] 424808 0
Baseline (T1), 2 weeks post-baseline (T2) and 6 weeks post-baseline (T3).

Eligibility
Key inclusion criteria
Children (aged 0.5 to 6 yrs) reviewed for suspected asthma (e.g. 2 or more reported wheeze episodes, chronic (>4 weeks) cough, or exertional breathlessness).
Minimum age
6 Months
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of (a) suspected chronic suppurative lung disease eg. chronic wet cough, (b) previous respiratory specialist-diagnosed asthma, (c) previously enrolled or (d) unable to complete PROs.

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
Efficacy
Statistical methods / analysis
Analysis of primary outcome: The proportion change in assessment between T3 to T1 will be assessed using McNemar’s test.

Secondary outcomes snalysis: Agreement with the independent specialist with weighted Kappa and change in PROs scores will be presented as means and SD and assessed by paired t-test (assuming normal distribution) and proportion with scores above MCID for each PRO in each group defined at T3 compared to groups classified at T1. We will compare these differences using McNemar’s test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2023
Actual
1/02/2024
Date of last participant enrolment
Anticipated
31/07/2027
Actual
Date of last data collection
Anticipated
15/08/2027
Actual
Sample size
Target
102
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD
Recruitment hospital [1] 25213 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [2] 25214 0
Gold Coast University Hospital - Southport
Recruitment hospital [3] 25215 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [4] 25216 0
Royal Darwin Hospital - Tiwi
Recruitment postcode(s) [1] 40884 0
4101 - South Brisbane
Recruitment postcode(s) [2] 40885 0
4215 - Southport
Recruitment postcode(s) [3] 40886 0
2145 - Westmead
Recruitment postcode(s) [4] 40887 0
0810 - Tiwi

Funding & Sponsors
Funding source category [1] 314318 0
Government body
Name [1] 314318 0
National Health and Medical Research Council - MRFF
Country [1] 314318 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
2 George St, Brisbane City QLD 4000
Country
Australia
Secondary sponsor category [1] 316271 0
None
Name [1] 316271 0
None
Address [1] 316271 0
None
Country [1] 316271 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313428 0
Children’s Health Queensland Human Research Ethics Committee
Ethics committee address [1] 313428 0
Ethics committee country [1] 313428 0
Australia
Date submitted for ethics approval [1] 313428 0
17/07/2023
Approval date [1] 313428 0
01/08/2023
Ethics approval number [1] 313428 0
HREC/23/QCHQ/100691

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

Contacts
Principal investigator
Name 128126 0
Prof Anne Chang
Address 128126 0
Queensland Children's Hospital
Stanley Street, South Brisbane, Qld 4101
Country 128126 0
Australia
Phone 128126 0
+61 7 30697283
Fax 128126 0
Email 128126 0
[email protected]
Contact person for public queries
Name 128127 0
Anne Chang
Address 128127 0
Queensland Children's Hospital
Stanley Street, South Brisbane, Qld 4101
Country 128127 0
Australia
Phone 128127 0
+61 7 30697283
Fax 128127 0
Email 128127 0
[email protected]
Contact person for scientific queries
Name 128128 0
Anne Chang
Address 128128 0
Queensland Children's Hospital
Stanley Street, South Brisbane, Qld 4101
Country 128128 0
Australia
Phone 128128 0
+61 7 30697283
Fax 128128 0
Email 128128 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As study involves Aboriginal and Torres Straits Islander children, specific permission is required and thus it is not possible to share the data.


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.