Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000780651
Ethics application status
Approved
Date submitted
6/12/2005
Date registered
7/12/2005
Date last updated
20/12/2018
Date data sharing statement initially provided
20/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Hypertonic saline during hospitalisation in Cystic Fibrosis study
Scientific title
Phase 3, placebo-controlled, parallel-group, randomised trial of the effect of nebulised hypertonic saline on the length of stay of people hospitalised with acute exacerbations of Cystic Fibrosis lung disease.
Secondary ID [1] 223 0
X05-0075
Universal Trial Number (UTN)
Trial acronym
HSHS Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic fibrosis 936 0
Condition category
Condition code
Human Genetics and Inherited Disorders 1006 1006 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
7% hypertonic saline with 0.25mg/mL quinine sulphate. The allocated trial solution is inhaled three times per day for the duration of a hospital admission.
Intervention code [1] 787 0
None
Comparator / control treatment
0.12% saline with 0.25mg/mL quinine sulphate. The allocated trial solution is inhaled three times per day for the duration of a hospital admission.
Control group
Placebo

Outcomes
Primary outcome [1] 1345 0
Duration of the length of stay in hospital
Timepoint [1] 1345 0
Secondary outcome [1] 2387 0
Lung function (FEV1, FVC, FEF2575).
Timepoint [1] 2387 0
Daily.
Secondary outcome [2] 2388 0
Oxygenation
Timepoint [2] 2388 0
Daily.
Secondary outcome [3] 2389 0
Symptom scores
Timepoint [3] 2389 0
Daily.
Secondary outcome [4] 2390 0
Quality of life
Timepoint [4] 2390 0
At admission, day 7, and discharge.
Secondary outcome [5] 2391 0
Exercise tolerance
Timepoint [5] 2391 0
At admission and day 7.
Secondary outcome [6] 2392 0
Tolerability of and adherence to the trial solutions throughout the admission.
Timepoint [6] 2392 0
Secondary outcome [7] 2393 0
Quantitative microbiology of sputum
Timepoint [7] 2393 0
At admission, day 7 and discharge.
Secondary outcome [8] 2394 0
Time to relapse.
Timepoint [8] 2394 0

Eligibility
Key inclusion criteria
Cystic fibrosis
Minimum age
17 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
B. cepacia, major haemoptysis in the last year, ITP, allergy to quinine sulphate, investigational drugs within last 30 days, previous lung transplant, pregnant or breastfeeding, thrombocytopaenia.

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)
Computerised, stratified randomisation performed by the trial pharmacist who is independent of all other activity in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated, stratified, random allocation using a minimisation algorithm
Masking / blinding
Blinded (masking 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
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Estimate - details unknown
Date of first participant enrolment
Anticipated
10/12/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
142
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1103 0
Charities/Societies/Foundations
Name [1] 1103 0
US CF Foundation
Country [1] 1103 0
United States of America
Primary sponsor type
Government body
Name
Sydney South West Area Health Service
Address
Country
Australia
Secondary sponsor category [1] 970 0
None
Name [1] 970 0
Nil
Address [1] 970 0
Country [1] 970 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2401 0
Sydney South West Area Health Service Ethics Review Committee
Ethics committee address [1] 2401 0
Ethics committee country [1] 2401 0
Australia
Date submitted for ethics approval [1] 2401 0
10/11/2005
Approval date [1] 2401 0
10/11/2005
Ethics approval number [1] 2401 0

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

Contacts
Principal investigator
Name 35280 0
Address 35280 0
Country 35280 0
Phone 35280 0
Fax 35280 0
Email 35280 0
Contact person for public queries
Name 9976 0
Sarah Newton-John
Address 9976 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9976 0
Australia
Phone 9976 0
+61 2 95156578
Fax 9976 0
+61 2 95505865
Email 9976 0
[email protected]
Contact person for scientific queries
Name 904 0
Mr Mark Elkins
Address 904 0
Department of Respiratory Medicine
Royal Prince Alfred Hospital
Level 11
E Block
Missenden Road
Camperdown NSW 2050
Country 904 0
Australia
Phone 904 0
+61 2 95158712
Fax 904 0
+61 2 95158196
Email 904 0
[email protected]

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
SourceTitleYear of PublicationDOI
Dimensions AIA randomised trial of hypertonic saline during hospitalisation for exacerbation of cystic fibrosis2016https://doi.org/10.1136/thoraxjnl-2014-206716
Dimensions AIInhaled hypertonic saline in adults hospitalised for exacerbation of cystic fibrosis lung disease: a retrospective study2012https://doi.org/10.1136/bmjopen-2011-000407
N.B. These documents automatically identified may not have been verified by the study sponsor.