Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000348651
Ethics application status
Approved
Date submitted
8/09/2005
Date registered
9/09/2005
Date last updated
14/12/2018
Date data sharing statement initially provided
14/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Positive Expiratory Pressure (PEP) Physiotherapy on the Duration of the Exacerbation-Free Period in People with Cystic Fibrosis (CF)
Scientific title
Effect of Positive Expiratory Pressure (PEP) Physiotherapy on the Duration of the Exacerbation-Free Period in People with Cystic Fibrosis (CF)
Secondary ID [1] 146 0
X03-0028
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic fibrosis 442 0
Condition category
Condition code
Human Genetics and Inherited Disorders 516 516 0 0
Cystic fibrosis
Physical Medicine / Rehabilitation 517 517 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Positive expiratory pressure (PEP) physiotherapy (b.d.). For 24 weeks or until the first exacerbation.
Intervention code [1] 411 0
None
Comparator / control treatment
No physiotherapy
Control group
Placebo

Outcomes
Primary outcome [1] 587 0
Duration of the Exacerbation-Free Period up to 24 weeks.
Timepoint [1] 587 0
Secondary outcome [1] 1243 0
Lung function
Timepoint [1] 1243 0
For 24 weeks or until the first exacerbation.
Secondary outcome [2] 1244 0
Quality of life
Timepoint [2] 1244 0
For 24 weeks or until the first exacerbation.
Secondary outcome [3] 1245 0
Exercise tolerance
Timepoint [3] 1245 0
For 24 weeks or until the first exacerbation.
Secondary outcome [4] 1246 0
Medication use
Timepoint [4] 1246 0
For 24 weeks or until the first exacerbation.
Secondary outcome [5] 1247 0
Exercise tolerance
Timepoint [5] 1247 0
At 6 weeks
Secondary outcome [6] 1248 0
Mucus plugging on high resolution CT
Timepoint [6] 1248 0
At 6 weeks

Eligibility
Key inclusion criteria
Cystic fibrosis, stable clinical condition with an FEV1 within 15% of their best recorded value as an outpatient for the preceding six months and no non-routine antibiotic use within the preceding two weeks.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
FEV1 <30%pred, PaO2 <50mmHg, PaCO2 >55mmHg, or are listed for transplant. Subjects will be required to have had at least one exacerbation requiring hospital admission for antibiotic therapy within the past year.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated random number list
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/09/2003
Actual
26/09/2003
Date of last participant enrolment
Anticipated
Actual
25/09/2004
Date of last data collection
Anticipated
Actual
25/09/2004
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 577 0
Government body
Name [1] 577 0
NHMRC
Country [1] 577 0
Australia
Primary sponsor type
Government body
Name
Sydney South West Area Health Service
Address
Country
Australia
Secondary sponsor category [1] 467 0
None
Name [1] 467 0
Nil
Address [1] 467 0
Country [1] 467 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1599 0
Sydney South West Area Health Service Ethics Review Committee
Ethics committee address [1] 1599 0
Ethics committee country [1] 1599 0
Australia
Date submitted for ethics approval [1] 1599 0
30/06/2003
Approval date [1] 1599 0
30/07/2003
Ethics approval number [1] 1599 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35230 0
Address 35230 0
Country 35230 0
Phone 35230 0
Fax 35230 0
Email 35230 0
Contact person for public queries
Name 9600 0
Ms Wendy Taylor
Address 9600 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9600 0
Australia
Phone 9600 0
+61 2 95156578
Fax 9600 0
+61 2 95505865
Email 9600 0
[email protected]
Contact person for scientific queries
Name 528 0
Mr Mark Elkins
Address 528 0
Department of Respiratory Medicine
Royal Prince Alfred Hospital
Level 11 E Block
Missenden Road
Camperdown NSW 2050
Country 528 0
Australia
Phone 528 0
+61 2 95158712
Fax 528 0
+61 2 95158196
Email 528 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.