ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12610000754044

Ethics application status

Approved

Date submitted

23/08/2010

Date registered

13/09/2010

Date last updated

22/09/2010

Type of registration

Retrospectively registered

Titles & IDs

Public title

Trial of different concentrations of nebulised saline for cystic fibrosis

Scientific title

The effect of nebulised 0.9% vs 3% vs 6% saline on lung function and quality of life in people with cystic fibrosis

Secondary ID [1]

There are no other identifying numbers for this trial

Universal Trial Number (UTN)

Trial acronym

Saline at lower tonicity in cystic fibrosis (SALTI-CF) trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

cystic fibrosis

Condition category

Condition code

Human Genetics and Inherited Disorders

Cystic fibrosis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Group A: Twice daily inhalation of 4mL of nebulised 6% hypertonic saline + 0.25mg/mL quinine sulphate for 16 weeks
Group B: Twice daily inhalation of 4mL of nebulised 3% hypertonic saline + 0.25mg/mL quinine sulphate for 16 weeks

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Group C: Twice daily inhalation of 4mL of nebulised 0.9% isotonic saline + 0.25mg/mL quinine sulphate for 16 weeks

Control group

Placebo

Outcomes

Primary outcome [1]

Lung function as measured by spirometry as the change in Forced Expiratory Volume in 1 second (FEV1) in units of percent predicted

Timepoint [1]

Week 0 (baseline)
Week 1
Week 4
Week 8
Week 16 (end of trial)

Secondary outcome [1]

Lung function as measured by spirometry in the change in Forced Vital Capacity (FVC) in units of percent predicted

Timepoint [1]

Week 0
Week 1
Week 4
Week 8
Week 16

Secondary outcome [2]

Lung function as measured by spirometry in the change in Forced Expiratory Volume 25-75 (FEF25-75) in units of percent predicted

Timepoint [2]

Week 0
Week 1
Week 4
Week 8
Week 16

Secondary outcome [3]

Quality of life as measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R)

Timepoint [3]

Week 0
Week 1
Week 4
Week 8
Week 16

Secondary outcome [4]

Quality of lfe as measured by the Medical Outcomes Survey Short Form-36 (SF-36)

Timepoint [4]

Week 0
Week 1
Week 4
Week 8
Week 16

Secondary outcome [5]

Exercise capacity as measured by the total distance covered in the Modified Shuttle Test-25 (MST-25)

Timepoint [5]

Week 0
Week 4
Week 16

Secondary outcome [6]

Exercise capacity as measured by the total exercise time in the Endurance Shuttle Test-25 (EST-25)

Timepoint [6]

Week 0
Week 4
Week 16

Secondary outcome [7]

Sputum bacterial diversity as measured by the acquisition or loss of bacterial organisms in expectorated sputum as measured by routine microscopy culture and sensitivity (M/C/S).

Timepoint [7]

Week 0
Week 16

Secondary outcome [8]

Tolerability of nebulised trial solution as measured by participant on a 10-point visual analogue scale

Timepoint [8]

Week 0
Week 1
Week 4
Week 8
Week 16

Secondary outcome [9]

Medication use as measured by number of doses of each prescribed medication

Timepoint [9]

Week 0
Weekly during trial (Week 1-week 16)

Secondary outcome [10]

Pulmonary exacerbations as measured by the Fuchs exacerbation criteria (presence of at least four of the following symptoms: change in sputum; new/increased haemoptysis; increased cough; increased dyspnoea; malaise/fatigue/lethargy; temperature>38C; anorexia/weight loss; sinus pain/tenderness; change in sinus discharge; change in auscultation; drop in FEV1>10% from best in last 6 months; change in xray/magnetic resonance imaging (MRI))

Timepoint [10]

Weekly during trial (Week 1-week 16)

Secondary outcome [11]

Adverse events (such as intolerable cough, sore throat, bronchospasm, haemoptysis, nausea, pulmonary exacerbation) as measured by presence of new symptoms, likelihood of being related to trial solution, severity of symptoms and time to resolution of symptoms.

Timepoint [11]

Weekly during trial (Week 1-week 16)

Secondary outcome [12]

Adherence to nebulisation of trial solution as measured weekly by self-report in patient diary and count of returned unused ampoules of trial solution at the end of the trial (week 16).

Timepoint [12]

Weekly during trial (Week 1-week 16)

Secondary outcome [13]

Administration time of nebulised trial solution as measured by stop watch from start to completion of one dose of trial inhalation solution

Timepoint [13]

Week 0
Week 1
Week 4
Week 8
Week 16

Eligibility

Key inclusion criteria

Provides informed consent Diagnosis of cystic fibrosis (positive sweat test or genotyping) Best FEV1 in the previous six months >20% of predicted normal value FEV1 >85% of best in the previous six months No non-routine antibiotics in the last 14 days

Minimum age

6 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Colonisation with Burkholderia cepacia
Major haemoptysis within the last 12 months
Pregnant or lactating females
Investigational drugs within the last 30 days
Previous lung transplant
Hypertonic saline within the last 14 days
Inhaled mannitol within the last 14 days

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)

Participants will be randomly allocated to one of three groups. The allocation will be performed by the Trial Pharmacist at the trial co-ordinating centre. The treatment allocation is recorded at the Trial Pharmacy and the random allocation lists, randomisation procedure and the unblinded treatment allocation is to be concealed from all other trial staff and the participant.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Random number generation with block allocation. Treatment allocation is stratified for: age, gender, FEV1

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

9/09/2010

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

140

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australian Cystic Fibrosis Research Trust

Address [1]

PO Box 254
North Ryde NSW 1670

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Prince Alfred Hospital

Address

Missenden Road
Camperdown NSW 2050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Prince Alfred Hospital

Ethics committee address [1]

Research Development Office
Level 3, Building 92
Royal Prince Alfred Hospital
Camperdown NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

08/12/2009

Ethics approval number [1]

HREC/09/RPAH/406

Summary

Brief summary

Background  People with Cystic Fibrosis (CF) have abnormally slow clearance of mucus from their airways. This causes chronic lung infection with obstruction of the airways by mucus. The chronic lung infection is characterised by (A) periods of acute worsening of the infection known as exacerbations, (B) progressive deterioration in lung function outside periods of exacerbation, (C) reduced quality of life, and (D) reduced ability to exercise. A strong, sterile, salt-water solution known as hypertonic saline is commonly used to assist clearance of mucus from the airways of people with CF. We know that long-term use of hypertonic saline where the concentration of salt is 7% produces significant benefits for people with CF in terms of (A) exacerbations, (B) lung function, and (C) quality of life. Some patients find 7% hypertonic saline difficult or impossible to tolerate. Some of these patients use lower concentrations of saline, although it is not known whether these are as effective, nor even whether they are more effective than doing nothing. Some patients often skip doses of hypertonic saline because the delivery is time consuming. Faster nebulisers are now available. The efficacy and tolerability of hypertonic saline delivered through these new nebulisers have not been formally assessed. Also, hypertonic saline has not been tested in patients with very badly affected lungs. 
Aim  One aim of the study is to determine the benefits of 6% and 3% hypertonic saline when delivered via a new, fast nebuliser, in people with CF. Another important aim is to determine whether hypertonic saline is tolerable when delivered via a fast nebuliser. A final aim is to compare the response to hypertonic saline among those with very badly affected lungs with the response to those with mildly and moderately affected lungs.
Method  140 people with CF will be enrolled in the study. For the first time, patients with very badly affected lungs will be eligible to enrol. All will be required to be in a stable clinical condition. At enrolment, lung function, quality of life, and some other relevant measures will be assessed. Participants will then be randomised to inhale either 6%, 3% or 0.9% saline. All other standard care will continue in all groups. Participants will be regularly assessed during the 16-week period over which they will inhale their allocated saline solution, twice a day, via a fast nebuliser. The progress of the groups inhaling the different concentrations of saline will be compared in terms of (A) exacerbations, (B) lung function, (C) quality of life and (D) exercise capacity. The tolerability of the solutions will also be recorded. We will also compare the response to the saline among those with very badly affected lungs to those with milder disease.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Professor Peter Bye

Address

Department of Respiratory Medicine
Level 11 West
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050

Country

Australia

Phone

+61 2 9515 7427

Fax

+61 2 9515 8196

peterb@med.usyd.edu.au

Contact person for scientific queries

Name

Professor Peter Bye

Address

Department of Respiratory Medicine
Level 11 West
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050

Country

Australia

Phone

+61 2 9515 7427

Fax

+61 2 9515 8196

peter.bye@sswahs.nsw.gov.au

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

Source	Title	Year of Publication	DOI
Dimensions AI	Mechanisms and applications of hypertonic saline	2011	https://doi.org/10.1258/jrsm.2011.s11101
Embase	Saline at lower tonicity in cystic fibrosis (SALTI-CF) trial comparing 0.9% versus 3% versus 6% nebulised saline.	2023	https://dx.doi.org/10.1183/13993003.00960-2021

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically