Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000349640
Ethics application status
Approved
Date submitted
8/09/2005
Date registered
9/09/2005
Date last updated
9/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of manual chest physiotherapy, positive expiratory pressure (PEP), and oscillating PEP on mucociliary clearance in subjects with CF
Scientific title
The effect of manual chest physiotherapy, positive expiratory pressure (PEP), and oscillating PEP on mucociliary clearance in subjects with CF
Secondary ID [1] 147 0
X03-0052
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic fibrosis 443 0
Condition category
Condition code
Human Genetics and Inherited Disorders 518 518 0 0
Cystic fibrosis
Physical Medicine / Rehabilitation 519 519 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Postural DrainagePositive Expiratory Pressure (PEP) PhysiotherapyOscillating PEP (Flutter).
Intervention code [1] 413 0
None
Comparator / control treatment
Also, cough control, but this intervention by necessity is a post comparison, not randomised like the first four interventions.Each intervention is for 20 minutes.
Control group
Placebo

Outcomes
Primary outcome [1] 588 0
Whole right lung mucociliary clearance
Timepoint [1] 588 0
Immediately after treatment.
Secondary outcome [1] 1249 0
Regional (central, peripheral) clearance
Timepoint [1] 1249 0
Immediately after treatment, follow-up clearance during the subsequent 90 minutes.
Secondary outcome [2] 1250 0
Cough
Timepoint [2] 1250 0
During and for 90 minutes after treatment.
Secondary outcome [3] 1251 0
Sputum weight
Timepoint [3] 1251 0
During treatment, perceived effect immediately after followup.

Eligibility
Key inclusion criteria
Cystic fibrosis, 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 treatment order allocation
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
18/04/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 578 0
Government body
Name [1] 578 0
NHMRC
Country [1] 578 0
Australia
Primary sponsor type
Government body
Name
Sydney South West Area Health Service
Address
Country
Australia
Secondary sponsor category [1] 468 0
None
Name [1] 468 0
Nil
Address [1] 468 0
Country [1] 468 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1600 0
Sydney South West Area Health Service Ethics Review Committee
Ethics committee address [1] 1600 0
Ethics committee country [1] 1600 0
Australia
Date submitted for ethics approval [1] 1600 0
Approval date [1] 1600 0
Ethics approval number [1] 1600 0

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

Contacts
Principal investigator
Name 35683 0
Address 35683 0
Country 35683 0
Phone 35683 0
Fax 35683 0
Email 35683 0
Contact person for public queries
Name 9602 0
Ms Wendy Taylor
Address 9602 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9602 0
Australia
Phone 9602 0
+61 2 95156578
Fax 9602 0
+61 2 95505865
Email 9602 0
[email protected]
Contact person for scientific queries
Name 530 0
Mr Mark Elkins
Address 530 0
Department of Respiratory Medicine
Royal Prince Alfred Hospital
Level 11 E Block
Missenden Road
Camperdown NSW 2050
Country 530 0
Australia
Phone 530 0
+61 2 95158712
Fax 530 0
+61 2 95158196
Email 530 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.