Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000053527
Ethics application status
Approved
Date submitted
3/02/2006
Date registered
7/02/2006
Date last updated
10/12/2018
Date data sharing statement initially provided
10/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot trial of the tolerability of hypertonic saline when delivered by a high-output nebuliser twice or four times daily to people with Cystic Fibrosis.
Scientific title
Pilot trial of the tolerability of hypertonic saline when delivered by a high-output nebuliser twice or four times daily to people with Cystic Fibrosis.
Secondary ID [1] 237 0
X05-0185
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic fibrosis 1017 0
Condition category
Condition code
Human Genetics and Inherited Disorders 1093 1093 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
4mL of 6% saline delivered via an eFlow nebuliser four times daily for 2 weeks.
Intervention code [1] 882 0
None
Comparator / control treatment
4mL of 6% saline delivered via an eFlow nebuliser twice daily for 2 weeks
Control group
Dose comparison

Outcomes
Primary outcome [1] 1459 0
Tolerance of the prescribed regimen of inhalation
Timepoint [1] 1459 0
Assessed at the end of the 2-week inhalation period
Secondary outcome [1] 2611 0
Lung function
Timepoint [1] 2611 0
Measured at baseline and at the end of the 2-week inhalation period.
Secondary outcome [2] 2612 0
Oxyhaemoglobin saturation
Timepoint [2] 2612 0
Measured at baseline and at the end of the 2-week inhalation period.
Secondary outcome [3] 2613 0
Symptom severity on a visual analogue scale
Timepoint [3] 2613 0
Measured at baseline and at the end of the 2-week inhalation period.
Secondary outcome [4] 2614 0
Quality of life scores
Timepoint [4] 2614 0
Measured at baseline and at the end of the 2-week inhalation period.
Secondary outcome [5] 2615 0
Cytokine concentration
Timepoint [5] 2615 0
Measured at baseline and at the end of the 2-week inhalation period.
Secondary outcome [6] 2616 0
Bacterial load.
Timepoint [6] 2616 0
Measured at baseline and at the end of the 2-week inhalation period.

Eligibility
Key inclusion criteria
Cystic fibrosis, member of RPA Hospital CF Clinic, stable clinical condition (no non-routine antibiotics in the previous 2 weeks), FEV1 >40% pred.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable/unwilling to provide informed consent, major haemoptysis in the previous year, pregnant or lactating, investigational drugs in the previous 30 days. There is no age limit.

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, with stratification for:(i) routine rhDNase use; Y/N(ii) FEV1 > 50% predicted on admission; Y/N(iii) routine HS use; Y/N(iv) presence of an epidemic P.aeruginosa pulsotype; Y/N(v) use of physiotherapy at least 5 / week; Y/N.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Estimate - details not known
Date of first participant enrolment
Anticipated
10/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1195 0
Charities/Societies/Foundations
Name [1] 1195 0
US CF Foundation
Country [1] 1195 0
United States of America
Primary sponsor type
Government body
Name
Sydney South West Area Health Service
Address
Country
Australia
Secondary sponsor category [1] 1056 0
None
Name [1] 1056 0
Nil
Address [1] 1056 0
Country [1] 1056 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2518 0
Sydney South West Area Health Service Ethics Review Committee
Ethics committee address [1] 2518 0
Ethics committee country [1] 2518 0
Australia
Date submitted for ethics approval [1] 2518 0
Approval date [1] 2518 0
27/01/2006
Ethics approval number [1] 2518 0

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

Contacts
Principal investigator
Name 35692 0
Address 35692 0
Country 35692 0
Phone 35692 0
Fax 35692 0
Email 35692 0
Contact person for public queries
Name 10071 0
Sarah Newton-John
Address 10071 0
Woolcock Institue of Research
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 10071 0
Australia
Phone 10071 0
+61 2 95156578
Fax 10071 0
+61 2 95505865
Email 10071 0
sarahnj@woolcock.org.au
Contact person for scientific queries
Name 999 0
Mr Mark Elkins
Address 999 0
Department of Respiratory Medicine
Royal Rpince Alfred Hospital
Level 11
E Block
Missenden Road
Camperdown NSW 2050
Country 999 0
Australia
Phone 999 0
+61 2 95158712
Fax 999 0
+61 2 95158196
Email 999 0
elkinsm@med.usyd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.