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Trial registered on ANZCTR


Registration number
ACTRN12613000778785
Ethics application status
Approved
Date submitted
10/07/2013
Date registered
11/07/2013
Date last updated
14/11/2018
Date data sharing statement initially provided
14/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical and psychosocial changes over late childhood and adolescence and early life determinants of long term clinical outcomes in cystic fibrosis Study
Scientific title
Clinical and psychosocial changes over late childhood and adolescence and early life determinants of long term clinical outcomes in cystic fibrosis Study
Secondary ID [1] 282808 0
Nil
Universal Trial Number (UTN)
U1111-1145-4497
Trial acronym
Follow-up ACFBAL Study (FAB) Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cystic fibrosis 289582 0
Condition category
Condition code
Human Genetics and Inherited Disorders 289916 289916 0 0
Cystic fibrosis
Respiratory 289920 289920 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Two study visits will occur from 12 months up to 3 years depending on the timing of the initial visit. At each visit clinical data will be recorded including: current symptoms, physical examination, weight, height, concomitant medications, spirometry, induced sputum collection and urine for matrix breakdown products and biomarkers of neutrophilic inflammation. Blood is collected routinely for review tests and will be collected and stored for inflammatory mediators. Health Related Quality of Life questionnaires and other standard measures of psychosocial health are completed and a bone density test (a DEXA), and a low dose chest CT scan will be done at the start and end of the study (again this is depending on the timing of the initial visit).
Intervention code [1] 287492 0
Not applicable
Comparator / control treatment
Not applicable - Observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289969 0
Repeated measures of the FEV1 best annual values as SD-scores (z-scores) over the study duration using a calibrated spirometer. These data will have been collected at each clinic visit attended by the patient.
Timepoint [1] 289969 0
3 years
Primary outcome [2] 289970 0
CT scan scores. A low dose spirometer-controlled inspiratory and expiratory volumetric chest CT scans using a standard protocol will be performed without contrast at the start of the study and in the final year.
Timepoint [2] 289970 0
3 years
Primary outcome [3] 289971 0
Association between the measures of Quality of Life and psychosocial functioning. The tests used are CFQ-R for parents and children and LSAC, . Parent social demographics, functioning and mental health (Brief COPE) will be done along with the Family Stress Scale. This is a composite primary outcome.
Timepoint [3] 289971 0
3 years
Secondary outcome [1] 303687 0
Nil
Timepoint [1] 303687 0
N/A

Eligibility
Key inclusion criteria
All children with cystic fibrosis who completed the ACFBAL Study (ACTRN12605000665639)
CE Wainwright et al. Effect of Bronchoalveolar lavage-Directed Therapy on Pseudomonas aeruginosa Infection and Structural Lung Injury in Children with Cystic Fibrosis A Randomized Trial. JAMA 13 July 2011; 306(2): 163-171.
Minimum age
9 Years
Maximum age
15 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children who did not not complete the ACFBAL study

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Statistical methods / analysis
The analyses will employ multivariable regression methods for which meaningful power calculations are difficult. However, the key questions addressed in these analyses will generally amount to comparisons of means between subgroups of the cohort, and indicative calculations can be made on that basis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 1231 0
Royal Children's Hospital - Herston
Recruitment hospital [2] 1233 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [3] 1234 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [4] 1235 0
Mater Children's Hospital - South Brisbane
Recruitment hospital [5] 1236 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [6] 1237 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [7] 1238 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [8] 4692 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 7144 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [2] 7146 0
3052 - Parkville
Recruitment postcode(s) [3] 7148 0
2145 - Westmead
Recruitment postcode(s) [4] 7149 0
4101 - South Brisbane
Recruitment postcode(s) [5] 7150 0
5006 - North Adelaide
Recruitment postcode(s) [6] 7151 0
2310 - Hunter Region
Recruitment postcode(s) [7] 7152 0
3800 - Monash University
Recruitment postcode(s) [8] 12267 0
4101 - Highgate Hill
Recruitment outside Australia
Country [1] 5180 0
New Zealand
State/province [1] 5180 0

Funding & Sponsors
Funding source category [1] 287586 0
Government body
Name [1] 287586 0
National Health and Medical Research Council (NHMRC)
Address [1] 287586 0
GPO Box 1421
Canberra
ACT 2601
Country [1] 287586 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia
Queensland
4072
Country
Australia
Secondary sponsor category [1] 286333 0
Government body
Name [1] 286333 0
Children's Health Hospital & Health Services
Address [1] 286333 0
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane 4101 QLD
Country [1] 286333 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289559 0
Children’s Health Services Queensland Human Research Ethics Committee
Ethics committee address [1] 289559 0
Level 7 Centre for Children's Health Research
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane
Queensland 4101
Ethics committee country [1] 289559 0
Australia
Date submitted for ethics approval [1] 289559 0
Approval date [1] 289559 0
20/11/2012
Ethics approval number [1] 289559 0
HREC/12/QRCH/171

Summary
Brief summary
The purpose of the study is to further improve outcomes in CF by developing a better understanding of the reasons for the decline in health status and lung function during adolescence, which is one of the key challenges facing clinicians.
We hope to do this by looking at such things as the
1) pathology involved in CF lung disease, 2) long term risks of emerging organisms, 3)potential effects of early therapeutic interventions, such as P. aeruginosa eradication, 4) metagenomic profile identifying bacteria in respiratory samples, 5) psychosocial factors, and 6) relationship between early life events and outcomes between 9 - 17 years of age.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 36966 0
Prof Claire Wainwright
Address 36966 0
5a Dept. of Respiratory & Sleep Medicine
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane
QLD 4101
Country 36966 0
Australia
Phone 36966 0
+617 3068 1111
Fax 36966 0
+61 7 3068 2309
Email 36966 0
Claire.Wainwright@health.qld.gov.au
Contact person for public queries
Name 36967 0
Ms Joyce Cheney
Address 36967 0
5a Dept. of Respiratory & Sleep Medicine
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane
QLD 4101
Country 36967 0
Australia
Phone 36967 0
+617 3069 7195
Fax 36967 0
+617 3069 7159
Email 36967 0
Joyce.Cheney@health.qld.gov.au
Contact person for scientific queries
Name 36968 0
Prof Claire Wainwright
Address 36968 0
5a Dept. of Respiratory & Sleep Medicine
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane
QLD 4101
Country 36968 0
Australia
Phone 36968 0
+617 3068 1111
Fax 36968 0
+617 3068 2309
Email 36968 0
Claire.Wainwright@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
A decision will be made on these matters in the coming months
What supporting documents are/will be available?
No other documents available
Summary results
No Results