Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000885695
Ethics application status
Approved
Date submitted
23/12/2013
Date registered
20/08/2014
Date last updated
20/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Forced Oscillation Technique variability in asthmatic children
Scientific title
Evaluation of Forced Oscillation Technique variability in asthmatic children and its relationship to asthma control and severity
Secondary ID [1] 283815 0
nil
Universal Trial Number (UTN)
U1111-1151-6028
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
asthma 290791 0
Condition category
Condition code
Respiratory 291159 291159 0 0
Asthma

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The variability of day to day measurements of forced oscillation technique (FOT) are being evaluated in children with asthma and compared to children without asthma. FOT measurements are made once daily during the five day study.

FOT is a tidal breathing test (performed during normal breathing) and is non-invasive. It takes 5 minutes. It is done at the asthma camp under supervision by someone trained in the technique
Intervention code [1] 288503 0
Not applicable
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291147 0
Variability in FOT. Variability will be assessed by looking at the between-session changes (i.e. day to day change) expressed as the within subject standard deviation across the FOT outcomes.
Timepoint [1] 291147 0
across five days of measurement starting from the baseline measurement (first day of the study)
Secondary outcome [1] 306136 0
relationship to asthma control and severity. These will be assessed based on the current recommendations of GINA (Global Initiative for Asthma). Questionnaire data. It has been developed specifically for this study based on components from other validated questionnaires (GINA, CAPS study).
Timepoint [1] 306136 0
at entry into study

Eligibility
Key inclusion criteria
physician diagnosed asthma
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
not able to perform FOT

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
comparison of day to day variability between cohorts using parametric and non parametric statistical tests as applicable.
All subjects attending the asthma camp were recruited (approximately 20-25) and will therefore form the subject number - power calculation of sample size was not possible as this type of data has not been described before. Each subject provides 5 days worth of daily measurements

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2008
Actual
1/12/2008
Date of last participant enrolment
Anticipated
30/01/2009
Actual
2/01/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288475 0
Government body
Name [1] 288475 0
NHMRC postgraduate scholarship (number 512108)
Country [1] 288475 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead
Address
Locked Bag 4001
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 287176 0
None
Name [1] 287176 0
Address [1] 287176 0
Country [1] 287176 0
Other collaborator category [1] 277746 0
Other Collaborative groups
Name [1] 277746 0
The Woolcock Medical Research Institute
Address [1] 277746 0
431 Glebe Point Road
Glebe, Sydney NSW 2037
Country [1] 277746 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290339 0
The Children's Hospital at Westmead Research Ethics Committee
Ethics committee address [1] 290339 0
Locked Bag 4001
Westmead
Sydney NSW 2145
Ethics committee country [1] 290339 0
Australia
Date submitted for ethics approval [1] 290339 0
Approval date [1] 290339 0
03/12/2007
Ethics approval number [1] 290339 0
07/CHW/14

Summary
Brief summary
This study is an observational study examining the day to day variation in FOT measures in 20 asthma subjects, and examining the relationship between the variability seen and asthma severity and symptom control
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45174 0
Dr Paul Robinson
Address 45174 0
The Children's Hospital at Westmead
Locked bag 4001
Westmead, Sydney, NSW 2145
Country 45174 0
Australia
Phone 45174 0
+61298453395
Fax 45174 0
Email 45174 0
[email protected]
Contact person for public queries
Name 45175 0
Dr Paul Robinson
Address 45175 0
The Children's Hospital at Westmead
Locked bag 4001
Westmead, Sydney, NSW 2145
Country 45175 0
Australia
Phone 45175 0
+61298453395
Fax 45175 0
Email 45175 0
[email protected]
Contact person for scientific queries
Name 45176 0
Dr Paul Robinson
Address 45176 0
The Children's Hospital at Westmead
Locked bag 4001
Westmead, Sydney, NSW 2145
Country 45176 0
Australia
Phone 45176 0
+61298453395
Fax 45176 0
Email 45176 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.