Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000060246
Ethics application status
Approved
Date submitted
26/11/2008
Date registered
23/01/2009
Date last updated
23/01/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Two new tests, Multiple Breath Washout Technique and Acoustic Severe Asthma Monitor, to measure lung function (breathing) in young children
Scientific title
Assessment of Lung Function Using the Multiple Breath Washout Technique and Acoustic Severe Asthma Monitor in Pre-School Children with a History of Wheezing
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wheeze 4027 0
Condition category
Condition code
Respiratory 4229 4229 0 0
Asthma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
There are two new tests that can be used to measure lung function in young children. These are called the multiple breath washout (MBW) and Acoustic Severe Asthma Monitor (ASAM). The MBW equipment is registered in Australia for use in children from birth. This system uses a multiple-breath washin/washout technique using sulphur-hexafluoride (SF6) as a tracer gas and a commercially available, TGA approved, ultrasonic flowmeter which indirectly measures inert tracer gas concentrations by continuous mainstream recording of the molar mass of the gas.
The ASAM is a new breathing test and is not yet registered in Australia so its use is experimental. The ASAM is a combination of two technologies; incorporating both passive and active methods for continuous monitoring of the asthmatic patient. The passive technology employs the detection of wheezes and coughing in the patient. The active technology, which injects sound into the upper airways, monitors the degree of occlusion of intrapulmonary airways that occurs during asthma attacks.
All participants undergo both tests in one session, with devices assigned in random order. Particpants will not have follow up as part of the study but will follow usual care. 50 children who wheeze and 50 children who don’t wheeze and have no other breathing problems shall be recruited and closeout shall occur within a year of commencement
Intervention code [1] 3928 0
Diagnosis / Prognosis
Comparator / control treatment
There are two new tests used to measure lung function in young children, the multiple breath washout (MBW) and Acoustic Severe Asthma Monitor (ASAM). The MBW equipment is registered in Australia for use and therefore most represents the control test in this study. All children within the study receive standard care and will have both tests in random order.
Control group
Active

Outcomes
Primary outcome [1] 5120 0
To determine the feasibility of MBW for the detection of lung function abnormalities and reversibility to bronchodilators in preschool children with a history of wheeze.
To determine the feasibility of ASAM for the detection of reversibility to bronchodilators in preschool children with a history of wheeze. Comparisson of results of both test shall be cross examined and directly compared
Timepoint [1] 5120 0
Data analysis will be competed off site post test administration, conclusions are expected at the completion of the study
Secondary outcome [1] 8622 0
The long term aim of this study is to develop techniques which provide objective markers of lung function and bronchodilator responsiveness in preschool children with wheezing with the two types of medical equipment tests and the direct comparison of results.
Timepoint [1] 8622 0
At completion of the last test administered to participants

Eligibility
Key inclusion criteria
child is between 3 and 6 years of age and has been referred to the hospital because of wheeze
Minimum age
3 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
has another respiratory problem such as cystic fibrosis

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4208 0
Commercial sector/Industry
Name [1] 4208 0
PulmoSonix Pty Ltd
Country [1] 4208 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Murdoch Children Research Institute
Address
C/- The Royal Childrens Hosptial, Melbourne
Flemington Road, Parkville
Victoria, 3052
Country
Australia
Secondary sponsor category [1] 3780 0
Commercial sector/Industry
Name [1] 3780 0
PulmoSonix Pty Ltd
Address [1] 3780 0
336A GlenHuntly Rd
Elsternwick VIC 3185
Country [1] 3780 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6261 0
Royal Children's Hospital, Melbourne Human Research Ethics Committee
Ethics committee address [1] 6261 0
Royal Children's Hospital Melbourne
Flemington Road
Parkville VIC 3052
Ethics committee country [1] 6261 0
Australia
Date submitted for ethics approval [1] 6261 0
Approval date [1] 6261 0
12/11/2008
Ethics approval number [1] 6261 0
28027A

Summary
Brief summary
Recent advances in diagnostic technologies and subsequent physiological research has lead to a number of techniques being widely available for use in the pre-school age group and resulted in the transition of these techniques into clinical practice. The use of these newer respiratory function techniques to assess airway function in pre-school children with recurrent wheeze may have major implications for our understanding of the pathophysiology of asthma.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29165 0
Address 29165 0
Country 29165 0
Phone 29165 0
Fax 29165 0
Email 29165 0
Contact person for public queries
Name 12322 0
Dr. Jo Harrison
Address 12322 0
Royal Children’s Hospital Melbourne
Flemington Road
Parkville VIC 3052
Country 12322 0
Australia
Phone 12322 0
+61 3 93455818
Fax 12322 0
Email 12322 0
jo.harrison@mcri.edu.au
Contact person for scientific queries
Name 3250 0
Dr. Jo Harrison
Address 3250 0
Royal Children’s Hospital Melbourne
Flemington Road
Parkville VIC 3052
Country 3250 0
Australia
Phone 3250 0
+61 3 93455818
Fax 3250 0
Email 3250 0
jo.harrison@mcri.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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