Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000361404
Ethics application status
Not yet submitted
Date submitted
29/06/2007
Date registered
6/07/2007
Date last updated
6/07/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pulsed Field Therapy, Pulsed Electromagnetic Resonance Therapy in The Treatment of Childhood Asthma. Clinical Trial 761100036
Scientific title
Children Under the Age of 16 Will Be Tested With A Therapeutic Intervention, Pulsed Electromagnetic Field Therapy and Compared To Treatment with Pharmaceutical Drugs For Treatment of Asthma as Measured By Symptoms, Amount of Medication Required and Peak Flows Over a 12 week Period. They will be followed up over a 52 week period for long term changes.
Secondary ID [1] 378 0
Biological Control Systems P/L: Clinical Trial 761100036
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood and infant asthma. 1919 0
Condition category
Condition code
Respiratory 2011 2011 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pulsed electro magnetic resonance therapy applied daily. Also known as pulsed magnetic field therapy. Asthma and overall health will be measured over a period of 12 weeks during use of pharmaceutical medication therapy and this will be the control group. Following this 12 weeks, pulsed electromagnetic field therapy (PERT) will be applied daily for a minimum of 4 hours and this will form the study intervention group ie test group.

There is no wash out period. There is no requirement to cease pharmaceutical medications unless and until the action of PERT has decreased asthma symptoms to the point that medication is no longer required. Pilot studies indicate in children that this occurs within days of commencing PERT therapy. The reason for this point of view is that we do no harm with our trials and by not asking participants to cease medications they have access to their existing treatment until no longer required.

Participants will receive PERT on a daily basis for 12 weeks for 4 hours daily. And this will form stage 1 of the trial. This is the primary outcome period of this trial.

We have found in pilot studies that ongoing use of PERT is likely to cause permanent changes to the point that the use of PERT is no longer required and asthma does not return.

Therefore participants will be asked to continue using 4 hours daily for a further 24 weeks after the initial 12 week period and then will be asked to cease all therapy for 12 weeks to see if the symptoms of asthma return or become worse.
Intervention code [1] 1863 0
Treatment: Devices
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 2837 0
Percentage reduction in asthma as measured using a rating scale based on number of day and night symptoms of asthma
Timepoint [1] 2837 0
Measured at 12 weeks, 24 weeks, 36 weeks and 52 weeks after intervention commencement.
Primary outcome [2] 2838 0
Number and type of medications required to treat asthma
Timepoint [2] 2838 0
Measured at 12 weeks, 24 weeks, 36 weeks and 52 weeks after intervention commencement.
Primary outcome [3] 2839 0
Peak flow
Timepoint [3] 2839 0
Measured at 12 weeks, 24 weeks, 36 weeks and 52 weeks after intervention commencement.
Secondary outcome [1] 4783 0
If children are asthma free at 36 weeks then intervention will be ceased and at 52 weeks trial participants will be tested for asthma to determine if this is a total cure ie no interventional therapy is required to be free of asthma.
Timepoint [1] 4783 0
Secondary outcome [2] 4784 0
Overall health will be measured using a computer generated and a interactive rating scale considering over 180 indicators of health being a mixture of items starting at “A” for allergies and ending at “W” for wound healing.
Timepoint [2] 4784 0

Eligibility
Key inclusion criteria
Children, infants and babies. Trial participants must have been diagnosed with asthma and have been treated for at least 3 months prior to enrolment.
Minimum age
3 Months
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Do not satisfy the inclusion criteria.

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2153 0
Commercial sector/Industry
Name [1] 2153 0
Biological Control Systems Pty Ltd.
Country [1] 2153 0
Primary sponsor type
Commercial sector/Industry
Name
Biological Control Systems Pty Ltd.
Address
Country
Australia
Secondary sponsor category [1] 1958 0
None
Name [1] 1958 0
Nil
Address [1] 1958 0
Country [1] 1958 0

Ethics approval
Ethics application status
Not yet submitted

Summary
Brief summary
The primary purpose is to test the hypothesis that pulsed electromagnetic resonance therapy (PERT) otherwise known as pulsed magnetic field therapy when applied regularly to children with chronic asthma can provide an outcome best described as a drug free cure which means that 95% of children in the trial will be free of the symptoms of asthma and the need for pharmaceutical intervention after 12 weeks of therapy and a further hypothesis is that the overall health of the group treated with PERT will be improved also as a result of PERT therapy and the reduction in side effects as a result of not requiring pharmaceutical medication.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27677 0
Address 27677 0
Country 27677 0
Phone 27677 0
Fax 27677 0
Email 27677 0
Contact person for public queries
Name 11052 0
John Charlick
Address 11052 0
Biological Control Systems P/L
45A Loch St
Claremont WA 6010
Country 11052 0
Australia
Phone 11052 0
+61 8 93864976
Fax 11052 0
+61 8 93868829
Email 11052 0
[email protected]
Contact person for scientific queries
Name 1980 0
John Charlick
Address 1980 0
Biological Control Systems P/L
45A Loch St
Claremont WA 6010
Country 1980 0
Australia
Phone 1980 0
+61 8 93864976
Fax 1980 0
+61 8 93868829
Email 1980 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.