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Trial registered on ANZCTR


Registration number
ACTRN12605000420640
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
Randomised 12 month trial of Non-Invasive Ventilation (NIV) with or without oxygen versus oxygen alone in treatment of sleep disordered breathing in Cystic Fibrosis
Scientific title
Randomised 12 month trial of Non-Invasive Ventilation (NIV) with or without oxygen versus oxygen alone in treatment of sleep disordered breathing in Cystic Fibrosis
Secondary ID [1] 287926 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 529 0
Condition category
Condition code
Human Genetics and Inherited Disorders 609 609 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomised to oxygen alone or NIV with or without oxygen, as titrated during polysomnography to maintain oxygen saturation >=90% in all sleep stages. Patients will be followed-up over 12 months. Repeat sleep studies at 3, 6 and 12 months. They will be censored if they undergo lung transplant or die. They cease the trial if defined as a 'treatment failure'
Intervention code [1] 496 0
Treatment: Devices
Comparator / control treatment
Control group was oxygen alone
Control group
Active

Outcomes
Primary outcome [1] 709 0
Number of treatment failures (PaCO2>60 or an increase >10mmHg from baseline; or increase TcCO2>10 from awake to sleep).
Timepoint [1] 709 0
This is time-to-event data, so "treatment failure" will be recorded if it occurs any time from baseline (day 0) within the 12 month time frame of the study.
Primary outcome [2] 710 0
Change in daytime PaCO2 from baseline to 12 months.
Timepoint [2] 710 0
12 months
Secondary outcome [1] 1467 0
Quality of life
Timepoint [1] 1467 0
Baseline, 3 months, 6 months, 12 months
Secondary outcome [2] 1468 0
Sleep quality
Timepoint [2] 1468 0
Baseline, 3 months, 6 months, 12 months
Secondary outcome [3] 1469 0
Lung function
Timepoint [3] 1469 0
Baseline, 3 months, 6 months, 12 months
Secondary outcome [4] 1470 0
Days on IV antibiotics
Timepoint [4] 1470 0
Total days on IV antibiotics within the 12 month study
Secondary outcome [5] 1471 0
Days in hospital (excluding trial measurement days)
Timepoint [5] 1471 0
Total days in hospital (excluding trial measurement days) within the 12 month study
Secondary outcome [6] 1472 0
Direct medical costs
Timepoint [6] 1472 0
Total direct medical costs within the 12 month study

Eligibility
Key inclusion criteria
Stable CF adults with total sleep time minimum average oxygen saturation <=90%
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute unstable hypercapnic respiratory failure (PaCO2>60; eligible for randomisation after acute treatment if stable off NIV for a minimum of two weeks); severe co-existing disease; persistent pneumothoraces; sputum colonised with burkolderia cepacia.

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)
Safety/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] 665 0
Government body
Name [1] 665 0
NHMRC Progress Grant
Address [1] 665 0
Director, Research Administration Section
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 665 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] 555 0
None
Name [1] 555 0
None
Address [1] 555 0
Country [1] 555 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1846 0
Royal Prince Alfred Hospital
Ethics committee address [1] 1846 0
Ethics committee country [1] 1846 0
Australia
Date submitted for ethics approval [1] 1846 0
Approval date [1] 1846 0
29/05/1998
Ethics approval number [1] 1846 0
Ethics committee name [2] 1847 0
Prince Charles Hospital
Ethics committee address [2] 1847 0
Ethics committee country [2] 1847 0
Australia
Date submitted for ethics approval [2] 1847 0
Approval date [2] 1847 0
21/11/2002
Ethics approval number [2] 1847 0

Summary
Brief summary
Last participant recruited 16/4/2010. Recruitment halted 2015 as no participant recruited in last 5 years. Data analysis ongoing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35699 0
Prof Peter Bye
Address 35699 0
Respiratory Medicine
Level 11
RPA Hospital
Missenden Road
Camperdown NSW 2050
Country 35699 0
Australia
Phone 35699 0
+61 2 9515 7427
Fax 35699 0
Email 35699 0
peter.bye@sydney.edu.au
Contact person for public queries
Name 9685 0
Dr Tiffany Dwyer
Address 9685 0
Department of Respiratory Medicine
Royal Prince Alfred Hospital
11 West
Missenden Road
Camperdown NSW 2050
Country 9685 0
Australia
Phone 9685 0
+61 2 95155234
Fax 9685 0
+61 2 95158196
Email 9685 0
tiffany.dwyer@sydney.edu.au
Contact person for scientific queries
Name 613 0
Prof Peter Bye
Address 613 0
Department of Respiratory Medicine
Royal Prince Alfred Hospital
11 West
Missenden Road
Camperdown NSW 2050
Country 613 0
Australia
Phone 613 0
+61 2 95157427
Fax 613 0
+61 2 95158196
Email 613 0
peter.bye@sydney.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