Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Sex
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
28/08/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
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
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
[email protected]
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
[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.