Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000665639
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
19/10/2005
Date last updated
9/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A multi-centre, randomised, controlled trial of bronchoalveolar lavage (BAL) directed therapy in young children with cystic fibrosis (CF).
Scientific title
A multi-centre, randomised, controlled trial of bronchoalveolar lavage (BAL) directed therapy to improve clinical outcomes in young children with cystic fibrosis.
Secondary ID [1] 262169 0
ACF BAL Study
Universal Trial Number (UTN)
Trial acronym
ACF BAL Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 813 0
Condition category
Condition code
Human Genetics and Inherited Disorders 877 877 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is designed to examine: 1.The clinical value, safety and cost effectiveness of flexible bronchoscopy (FB) and bronchoalveolar lavage (BAL) to identify lower respiratory tract infection (especially Pseudomonas aeruginosa (Pa)) in infants and young children with cystic fibrosis (CF) and to direct therapy in an attempt to eradicate proven early lung infection and delay progressive lung disease. 2. The role of and relationship between lower respiratory infection and inflammation in the development and pathophysiology of lung disease in a large cohort of CF infants recruited prospectively and followed longitudinally.
Intervention code [1] 479 0
Treatment: Other
Comparator / control treatment
Standard therapy based on clinical status and oropharyngeal specimen culture
Control group
Active

Outcomes
Primary outcome [1] 1129 0
Prevalence of P. aeruginosa on bronchoalveolar lavage (BAL)
Timepoint [1] 1129 0
Primary outcomes for all children are measured at age 5 years
Primary outcome [2] 1130 0
High-resolution computerised tomography (HRCT) scan of the chest (Total score)
Timepoint [2] 1130 0
Primary outcomes for all children are measured at age 5 years
Secondary outcome [1] 2083 0
Nutritional and clinical parameters and lung function for all children + components of HRCT scores
Timepoint [1] 2083 0
At age 5 years.
Secondary outcome [2] 2084 0
Detailed health economic assessment is also being undertaken at this time.
Timepoint [2] 2084 0
At age 5 years.

Eligibility
Key inclusion criteria
All infants diagnosed with cystic fibrosis through the neonatal screening program in Queensland, New South Wales, South Australia, Victoria, Auckland and North Auckland Infants diagnosed with meconium ileus may be enrolled when diagnosis of cystic fibrosis is confirmed. A diagnosis of cystic fibrosis must be confirmed with a positive sweat chloride (Gibson Cooke with a chloride > 60mmol/l).Informed consent from parents or guardians.
Minimum age
0 Years
Maximum age
6 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Informed consent cannot be obtained. Infant is severely ill at the time of diagnosis and requires ventilatory support. Family are planning to move overseas in the next few years.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation key is concealed and held at the Clinical Epidemiology and Biostatistics Unit (CEBU), Royal Children's Hospital, Melbourne.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
CEBU staff used the next number in sequence on the preprepared randomisation lists generated by computer software Stata. Participants were randomised in blocks by CF Centre and gender to each treatment arm after obtaining informed parental consent.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/11/1999
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
165
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 205 0
New Zealand
State/province [1] 205 0

Funding & Sponsors
Funding source category [1] 966 0
Government body
Name [1] 966 0
NHMRC grant
Country [1] 966 0
Australia
Funding source category [2] 967 0
Hospital
Name [2] 967 0
Royal Children's Hospital Foundation
Country [2] 967 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
GPO Box 1421
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 835 0
Commercial sector/Industry
Name [1] 835 0
The only support from Novartis Pharmaceuticals was the supply of TOBI and nebuliser masks during the study
Address [1] 835 0
North Ryde NSW
Country [1] 835 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2265 0
Royal Children's Hospital
Ethics committee address [1] 2265 0
Brisbane
Ethics committee country [1] 2265 0
Australia
Date submitted for ethics approval [1] 2265 0
Approval date [1] 2265 0
Ethics approval number [1] 2265 0
Ethics committee name [2] 2266 0
Royal Children's Hospital
Ethics committee address [2] 2266 0
Melbourne
Ethics committee country [2] 2266 0
Australia
Date submitted for ethics approval [2] 2266 0
Approval date [2] 2266 0
Ethics approval number [2] 2266 0
Ethics committee name [3] 2267 0
Children's Hospital at Westmead
Ethics committee address [3] 2267 0
Sydney
Ethics committee country [3] 2267 0
Australia
Date submitted for ethics approval [3] 2267 0
Approval date [3] 2267 0
Ethics approval number [3] 2267 0
Ethics committee name [4] 2268 0
Monash Medical Centre
Ethics committee address [4] 2268 0
Melbourne
Ethics committee country [4] 2268 0
Australia
Date submitted for ethics approval [4] 2268 0
Approval date [4] 2268 0
Ethics approval number [4] 2268 0
Ethics committee name [5] 2269 0
Women's and Children's Hospital
Ethics committee address [5] 2269 0
Adelaide
Ethics committee country [5] 2269 0
Australia
Date submitted for ethics approval [5] 2269 0
Approval date [5] 2269 0
Ethics approval number [5] 2269 0
Ethics committee name [6] 2270 0
Mater Children's Hospital
Ethics committee address [6] 2270 0
Brisbane
Ethics committee country [6] 2270 0
Australia
Date submitted for ethics approval [6] 2270 0
Approval date [6] 2270 0
Ethics approval number [6] 2270 0
Ethics committee name [7] 2271 0
John Hunter Hospital
Ethics committee address [7] 2271 0
Newcastle
Ethics committee country [7] 2271 0
Australia
Date submitted for ethics approval [7] 2271 0
Approval date [7] 2271 0
Ethics approval number [7] 2271 0
Ethics committee name [8] 2272 0
Starship Hospital
Ethics committee address [8] 2272 0
Ethics committee country [8] 2272 0
New Zealand
Date submitted for ethics approval [8] 2272 0
Approval date [8] 2272 0
28/05/1998
Ethics approval number [8] 2272 0

Summary
Brief summary
1. This study will examine the use and safety of FB and BAL to identify lower respiratory tract infection (especially PA) in infants and young children with CF and direct therapy in an attempt to eradicate proven early lung infection.
2. The role of infection and inflammation in the development of CF lung disease will be examined in a large cohort of CF infants recruited prospectively and followed longitudinally.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36361 0
Prof Claire Wainwright
Address 36361 0
5a Dept. of Respiratory & Sleep Medicine
Lady Cilento Children's Hospital
Stanley Street
South Brisbane 4101
Country 36361 0
Australia
Phone 36361 0
+617 3068 1111
Fax 36361 0
+61 7 3068 2309
Email 36361 0
Claire.Wainwright@health.qld.gov.au
Contact person for public queries
Name 9668 0
Ms Ms Joyce Cheney
Address 9668 0
5a Dept. of Respiratory & Sleep Medicine
Lady Cilento Children's Hospital
Stanley Street
South Brisbane 4101
Country 9668 0
Australia
Phone 9668 0
+617 3069 7195
Fax 9668 0
+617 3068 2309
Email 9668 0
Joyce.Cheney@health.qld.gov.au
Contact person for scientific queries
Name 596 0
Prof Claire Wainwright
Address 596 0
5a Dept. of Respiratory & Sleep Medicine
Lady Cilento Children's Hospital
Stanley Street
South Brisbane 4101
Country 596 0
Australia
Phone 596 0
+617 3068 1111
Fax 596 0
+617 3068 2309
Email 596 0
Claire.Wainwright@health.qld.gov.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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