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Trial registered on ANZCTR


Registration number
ACTRN12605000470695
Ethics application status
Approved
Date submitted
8/09/2005
Date registered
23/09/2005
Date last updated
23/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Bi-Level Non-Invasive Ventilation on Mucociliary Clearance in Subjects with Cystic Fibrosis
Scientific title
The Effect of Bi-Level Non-Invasive Ventilation on Mucociliary Clearance in Subjects with Cystic Fibrosis
Secondary ID [1] 176 0
X02-0024
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic fibrosis 589 0
Condition category
Condition code
Human Genetics and Inherited Disorders 661 661 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The active intervention is non-invasive bi-level ventilatory support.
Intervention code [1] 408 0
None
Comparator / control treatment
The control intervention is spontaneous breathing on room air. Each is applied for 90 minutes.
Control group
Placebo

Outcomes
Primary outcome [1] 789 0
Whole right lung mucociliary clearance during a 90 minute treatment
Timepoint [1] 789 0
Secondary outcome [1] 1596 0
Regional (central and peripheral) clearance.
Timepoint [1] 1596 0
During a 90 minute treatment.
Secondary outcome [2] 1597 0
Respiratory rate
Timepoint [2] 1597 0
During a 90 minute treatment.

Eligibility
Key inclusion criteria
Cystic fibrosis, member of RPA Hospital CF Clinic, stable clinical condition (FEV1 within 10% of best for the previous 6 months).
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable/unwilling to provide informed consent, already received allowed radiation dose for research purposes.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated random number list
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)

Funding & Sponsors
Funding source category [1] 731 0
Government body
Name [1] 731 0
NHMRC
Address [1] 731 0
Country [1] 731 0
Australia
Primary sponsor type
Government body
Name
Sydney South West Area Health Service
Address
Country
Australia
Secondary sponsor category [1] 606 0
None
Name [1] 606 0
Nil
Address [1] 606 0
Country [1] 606 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1926 0
Sydney South West Area Health Service Ethics Review Committee
Ethics committee address [1] 1926 0
Ethics committee country [1] 1926 0
Australia
Date submitted for ethics approval [1] 1926 0
Approval date [1] 1926 0
Ethics approval number [1] 1926 0

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

Contacts
Principal investigator
Name 35856 0
Address 35856 0
Country 35856 0
Phone 35856 0
Fax 35856 0
Email 35856 0
Contact person for public queries
Name 9597 0
Ms Wendy Taylor
Address 9597 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9597 0
Australia
Phone 9597 0
+61 2 95156578
Fax 9597 0
+61 2 95505865
Email 9597 0
wtaylor@woolcock.org.au
Contact person for scientific queries
Name 525 0
Mr Mark Elkins
Address 525 0
Department of Respiratory Medicine
Royal Prince Alfred Hospital
Level 11 E Block
Missenden Road
Camperdown NSW 2050
Country 525 0
Australia
Phone 525 0
+61 2 95158712
Fax 525 0
+61 2 95158196
Email 525 0
elkinsm@med.usyd.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary