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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00484263




Registration number
NCT00484263
Ethics application status
Date submitted
7/06/2007
Date registered
8/06/2007
Date last updated
23/06/2011

Titles & IDs
Public title
The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non Cystic Fibrosis Bronchiectasis
Scientific title
The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non-cystic Fibrosis Bronchiectasis.
Secondary ID [1] 0 0
T10716
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Hypertonic saline 6% -

Active comparator: 1 -


Treatment: Drugs: Hypertonic saline 6% -
Hypertonic saline (6%) - 5mls twice a day via a nebuliser for 12 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of pulmonary exacerbations
Timepoint [1] 0 0
One year
Secondary outcome [1] 0 0
- St George Respiratory questionnaire - Leicester Cough Questionnaire - Lung Function Tests
Timepoint [1] 0 0
One year

Eligibility
Key inclusion criteria
* diagnosis of bronchiectasis on high resolution computer tomography
* at least 2 respiratory exacerbations per year over the past 2 years
* producing sputum daily
* in a stable clinical state
* over 18 years of age.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* cystic fibrosis
* Positive response to hypertonic saline challenge - FEV 1 decreased by = 15%
* FEV 1 = 1L

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2009
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3126 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Anne Holland, PhD, BAppSc
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00484263