Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001164785
Ethics application status
Not yet submitted
Date submitted
29/09/2013
Date registered
21/10/2013
Date last updated
21/10/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Do Defects in the Innate Immune System Contribute to Non-Cystic Fibrosis Bronchiectasis in Maori and Pacific Island Children?
Scientific title
In Maori and Pacific Island children with Non-Cystic Fibrosis Bronchiectasis, will measurement of CD62 Ligand shedding detect defects of the innate immune system?
Secondary ID [1] 283325 0
Nil
Universal Trial Number (UTN)
U1111-1148-1091
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Cystic Fibrosis Bronchiectasis in Maori and Pacific Island Children 290217 0
Innate Immune Defects in Maori and Pacific Island Children 290218 0
Condition category
Condition code
Respiratory 290607 290607 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 290608 290608 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Measurement of CD62 Ligand shedding using flow cytometry to screen for defects in the Toll-like Receptor pathway of the innate immune system in Maori and Pacifica children with bronchiectasis. Participants will have CD62 Ligand shedding measured once only. Time to results is 2 hours. The total duration of the trial is 1 year with no follow up period.
Intervention code [1] 288047 0
Early detection / Screening
Comparator / control treatment
Measurement of CD62 Ligand shedding using flow cytometry to screen for defects in the Toll-like receptor pathway of the innate immune system in healthy Maori and Pacific children (healthy controls).
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290622 0
To detect defects in the innate immune system in Maori and Pacifica children with bronchiectasis by measurement of CD62 Ligand shedding using flow cytometry.
Timepoint [1] 290622 0
Once only within one year of study commencement
Secondary outcome [1] 304923 0
Utility of CD62 Ligand shedding assay using flow cytometry as a screen for innate immune defects.
Timepoint [1] 304923 0
Once only within one year of study commencement

Eligibility
Key inclusion criteria
Bronchiectasis group: <15 years old at time of enrolment, Maori or Pacifica, confirmed bronchiectasis on HRCT scan, clinical diagnosis by respiratory physician, consent to study.
Healthy control group: <15 years old at time of enrolment, Maori or Pacifica, consent to study.
Minimum age
No limit
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Bronchiectasis group: Cystic fibrosis not excluded as diagnosis, known primary immunodeficiency, primary ciliary dyskinesia, non-consent to study.
Healthy control group: Infectious comorbidities, history of recurrent infections or Rheumatic Fever, non-consent

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)
Bronchiectasis group. Participants will be identified from the Starship Children's Hospital Bronchiectasis database. Participants and their families will be provided with written and verbal information. Allocation is not concealed.
Healthy control group: Participants will be identified from the Starship Children's Hospital Orthopaedic Fracture Clinic or operating lists. Participants and their families will be provided with written and verbal information. Allocation is not concealed.
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
Positive findings in 10% of the study population will be considered significant. However any positive findings will be considered clinically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/01/2014
Actual
Date of last participant enrolment
Anticipated
31/08/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 5451 0
New Zealand
State/province [1] 5451 0
Auckland

Funding & Sponsors
Funding source category [1] 288061 0
Hospital
Name [1] 288061 0
Auckland District Health Board - Starship Foundation Fellowship
Country [1] 288061 0
New Zealand
Primary sponsor type
Hospital
Name
Starship Clinical Immunology and Allergy Department
Address
Starship Children's Hospital
Park Road
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 286783 0
Hospital
Name [1] 286783 0
Starship Respiratory Department
Address [1] 286783 0
Starship Children's Hospital
Park Road
Grafton
Auckland 1023
Country [1] 286783 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289986 0
Health and Disability Ethics Committee
Ethics committee address [1] 289986 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington
6011
Ethics committee country [1] 289986 0
New Zealand
Date submitted for ethics approval [1] 289986 0
01/10/2013
Approval date [1] 289986 0
Ethics approval number [1] 289986 0

Summary
Brief summary
Bronchiectasis is an abnormal and irreversible dilatation of the bronchi or breathing tubes, leading to chronic cough, chest infections and breathing difficulties. It is common and severe in New Zealand with a prevalence of 1/3000 overall, but 1/1200 Maori and 1/650 Pacifica children. The cause is unknown in the majority of cases. Our clinical suspicion is that there is more than just social determinants placing these children at risk. The innate immune system provides the first line of defence against infection. Toll-like receptors (TLR) are part of the innate immune system that recognise pathogens, and it is possible to screen for problems with TLR by measuring the shedding of a protein called CD62 Ligand from cells.

Our hypothesis is that defects in the Toll-like Receptor pathway of the innate immune system contribute to high rates of bronchiectasis in Maori and Pacifica children.

Identification of a genetic predisposition to defects in the innate immune system would enable us to identify children at risk of bronchiectasis and intensify early prevention and treatment measures in order to reduce health inequalities.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43374 0
Dr Annaliesse Blincoe
Address 43374 0
Department of Paediatric Clinical Immunology and Allergy
Starship Children's Hospital
Private Bag 92024
Auckland
Country 43374 0
New Zealand
Phone 43374 0
+64 9 3074949
Fax 43374 0
Email 43374 0
[email protected]
Contact person for public queries
Name 43375 0
Dr Annaliesse Blincoe
Address 43375 0
Department of Paediatric Clinical Immunology and Allergy
Starship Children's Hospital
Private Bag 92024
Auckland
Country 43375 0
New Zealand
Phone 43375 0
+64 9 3074949
Fax 43375 0
Email 43375 0
[email protected]
Contact person for scientific queries
Name 43376 0
Dr Annaliesse Blincoe
Address 43376 0
Department of Paediatric Clinical Immunology and Allergy
Starship Children's Hospital
Private Bag 92024
Auckland
Country 43376 0
New Zealand
Phone 43376 0
+64 9 3074949
Fax 43376 0
Email 43376 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.