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Trial registered on ANZCTR


Registration number
ACTRN12605000437662
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
16/09/2005
Date last updated
18/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bi-level Ventilatory Support during exacerbations of Cystic Fibrosis
Scientific title
Randomised trial of short-term effects of bi-level ventilatory support (BVS) on lung function, gas exchange, exercise capacity, quantitative sputum microbiology and quality of life during an exacerbation of Cystic Fibrosis
Secondary ID [1] 287925 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 549 0
Condition category
Condition code
Human Genetics and Inherited Disorders 627 627 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomised to receive BVS in combination with standard therapy or not throughout a hospital admission for an acute respiratory exacerbation. BVS will be applied when the patient is awake, as an adjunct to chest physiotherapy with a physiotherapist, and for self use for physiotherapy or dyspnoea relief.
Intervention code [1] 493 0
Treatment: Devices
Comparator / control treatment
Control treatment was standard inpatient therapy throughout a hospital admission for an acute respiratory exacerbation
Control group
Active

Outcomes
Primary outcome [1] 734 0
Rate of improvement in daily lung function and symptom severity scores.
Timepoint [1] 734 0
Measured daily
Primary outcome [2] 735 0
Absolute improvement in lung function and symptom severity scores for admission and discharge.
Timepoint [2] 735 0
At admission and discharge.
Secondary outcome [1] 1506 0
Exercise capacity
Timepoint [1] 1506 0
Admission, discharge.
Secondary outcome [2] 1507 0
Quantitative sputum microbiology
Timepoint [2] 1507 0
Admission, day 6, discharge.
Secondary outcome [3] 1508 0
Quality of life
Timepoint [3] 1508 0
Admission, discharge.
Secondary outcome [4] 1509 0
Dyspnoea
Timepoint [4] 1509 0
Admission, day 6, discharge.
Secondary outcome [5] 1510 0
Arterial blood gas
Timepoint [5] 1510 0
Admission, discharge.
Secondary outcome [6] 1511 0
Respiratory muscle strength
Timepoint [6] 1511 0
Admission, day 1, day 6, discharge.
Secondary outcome [7] 1512 0
Oxygen saturation, heart rate, respiratory rate post physiotherapy
Timepoint [7] 1512 0
Day 1, day 6, discharge.
Secondary outcome [8] 1513 0
Time to next hospital re-admission.
Timepoint [8] 1513 0
Next hospital re-admission recorded/measured on admission to hospital for an acute exacerbation of cystic fibrosis (i.e. "time to event" data).

Eligibility
Key inclusion criteria
Acute respiratory exacerbation of Cystic Fibrosis (Fuchs et al 1994) requiring IV antibiotics and admission to hospital; aged over 17 years; FEV1 <60% predicted on admission.
Minimum age
17 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Already using BVS or daytime respiratory failure on admission; problem pneumothoraces; recent massive haemoptysis; pregnant; sputum colonised with burkolderia cepacia; previous participation in this study; admitted for lung transplant work-up.

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 randomisation table. Block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2003
Actual
9/10/2003
Date of last participant enrolment
Anticipated
Actual
14/06/2006
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 684 0
Government body
Name [1] 684 0
NHMRC Progress Grant
Country [1] 684 0
Australia
Primary sponsor type
Government body
Name
SWSAHS
Address
Level 11, KGV Building
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 573 0
None
Name [1] 573 0
None
Address [1] 573 0
Country [1] 573 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1878 0
Royal Prince Alfred Hospital
Ethics committee address [1] 1878 0
Ethics committee country [1] 1878 0
Australia
Date submitted for ethics approval [1] 1878 0
Approval date [1] 1878 0
08/09/2003
Ethics approval number [1] 1878 0
Ethics committee name [2] 1879 0
Prince Charles Hospital
Ethics committee address [2] 1879 0
Ethics committee country [2] 1879 0
Australia
Date submitted for ethics approval [2] 1879 0
Approval date [2] 1879 0
11/12/2003
Ethics approval number [2] 1879 0

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

Contacts
Principal investigator
Name 35178 0
Dr Tiffany Dwyer
Address 35178 0
Respiratory Medicine
Level 11
RPA Hospital
Missenden Rd
Camperdown NSW 2050
Country 35178 0
Australia
Phone 35178 0
61 2 9515 5234
Fax 35178 0
Email 35178 0
tiffany.dwyer@sydney.edu.au
Contact person for public queries
Name 9682 0
Tiffany Dwyer
Address 9682 0
Department of Respiratory Medicine
Royal Prince Alfred Hospital
11 West
Missenden Road
Camperdown NSW 2050
Country 9682 0
Australia
Phone 9682 0
+61 2 95155234
Fax 9682 0
+61 2 95158196
Email 9682 0
tdwyer@med.usyd.edu.au
Contact person for scientific queries
Name 610 0
Peter Bye
Address 610 0
Department of Respiratory Medicine
Royal Prince Alfred Hospital
11 West
Missenden Road
Camperdown NSW 2050
Country 610 0
Australia
Phone 610 0
+61 2 95157427
Fax 610 0
+61 2 95158196
Email 610 0
peterb@med.usyd.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseNon-invasive ventilation used as an adjunct to airway clearance treatments improves lung function during an acute exacerbation of cystic fibrosis: a randomised trial.2015https://dx.doi.org/10.1016/j.jphys.2015.05.019
N.B. These documents automatically identified may not have been verified by the study sponsor.