Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000367448
Ethics application status
Approved
Date submitted
6/07/2007
Date registered
13/07/2007
Date last updated
6/04/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The long term effect of inhaled hypertonic saline (6%) in non-cystic fibrosis bronchiectasis.
Scientific title
The long term effect of inhaled hypertonic saline (6%) on pulmonary exacerbations, quality of life and lung function in patients with non-cystic fibrosis bronchiectasis.
Secondary ID [1] 388 0
ClinicalTrials.gov: NCT00484263
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-cystic fibrosis bronchiechtasis 1945 0
Condition category
Condition code
Respiratory 2042 2042 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hypertonic saline (6%) - 5mls nebulsied twice a day for 12 months
Intervention code [1] 1877 0
Treatment: Drugs
Comparator / control treatment
Isotonic saline (0/9%) nebulised twice a day for 12 months
Control group
Placebo

Outcomes
Primary outcome [1] 2868 0
Pulmonary exacerbations
Timepoint [1] 2868 0
Symptoms monitored on a daily basis for 12 months
Secondary outcome [1] 4836 0
Quality of life
Timepoint [1] 4836 0
Assessed at baseline and then at 3, 6 and 12 months
Secondary outcome [2] 4837 0
Antibiotic use
Timepoint [2] 4837 0
Monitired on a dialy basis for 12 months
Secondary outcome [3] 4838 0
Lung function
Timepoint [3] 4838 0
Assessed at baseline and then at 3, 6 and 12 months

Eligibility
Key inclusion criteria
Diagnosis of bronchiectasis using high resolution computer tomography (HRCT), at least two pulmonary exacerbations over past year, producing sputum daily, stable clinical state
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cystic fibrosis, clinically unstable, unable to tolerate hypertonic saline (6%)

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)
Simple randomisation by using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The subjects, the assessor, the therapist and the data analyst are all blinded to the allocation of subjects.
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/12/2007
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] 2184 0
Charities/Societies/Foundations
Name [1] 2184 0
Alfred Research Trust
Country [1] 2184 0
Australia
Primary sponsor type
Hospital
Name
Alfred Hospital, Physiotherapy Department
Address
Alfred Hospital, Commercial Road, Melbourne 3004
Country
Australia
Secondary sponsor category [1] 1971 0
None
Name [1] 1971 0
N/A
Address [1] 1971 0
Country [1] 1971 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3981 0
The Alfred Hospital
Ethics committee address [1] 3981 0
Ethics committee country [1] 3981 0
Australia
Date submitted for ethics approval [1] 3981 0
Approval date [1] 3981 0
Ethics approval number [1] 3981 0

Summary
Brief summary
The main purpose of this study is to determine whether the long term inhalation of a salt solution will decrease the number of lung infections and improve the quality of life of people with bronchiectasis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27691 0
Address 27691 0
Country 27691 0
Phone 27691 0
Fax 27691 0
Email 27691 0
Contact person for public queries
Name 11066 0
Mrs Caroline Nicolson
Address 11066 0
Physiotherapy Department
The Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country 11066 0
Australia
Phone 11066 0
+61 3 90763450
Fax 11066 0
+61 3 90762702
Email 11066 0
[email protected]
Contact person for scientific queries
Name 1994 0
Dr Anne Holland
Address 1994 0
Physiotherapy Department
The Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country 1994 0
Australia
Phone 1994 0
+61 3 90763450
Fax 1994 0
+61 3 90762702
Email 1994 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
SourceTitleYear of PublicationDOI
EmbaseInhaled medication therapy for bronchiectasis: status quo and the next frontier.2018https://dx.doi.org/10.1080/13543784.2018.1439919
EmbaseAdvances in pharmacotherapy for bronchiectasis in adults.2023https://dx.doi.org/10.1080/14656566.2023.2210763
Dimensions AIThe long term effect of inhaled hypertonic saline 6% in non-cystic fibrosis bronchiectasis2012https://doi.org/10.1016/j.rmed.2011.12.021
N.B. These documents automatically identified may not have been verified by the study sponsor.