Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000673943
Ethics application status
Approved
Date submitted
29/04/2011
Date registered
4/07/2011
Date last updated
4/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised trial of the effect of timing of nebulised hypertonic saline in relation to airway clearance physiotherapy, in people with Cystic Fibrosis lung disease.
Scientific title
Randomised trial of the effect of timing of nebulised hypertonic saline in relation to airway clearance physiotherapy, on subjective efficacy, tolerability and overall satisfaction, and lung function parameters in adults with Cystic Fibrosis lung disease.
Secondary ID [1] 260079 0
Nil
Universal Trial Number (UTN)
U1111-1121-0964
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 252185 0
Condition category
Condition code
Respiratory 252383 252383 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 268331 268331 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following consent, subjects will be randomised to three timing regimes of 6% hypertonic saline (HS) inhalation over three days. Each day subjects will perform baseline spirometry, inhalation of bronchodilator, and inhalation of HS: either immediatly pre (not greater than 30 minutes pre), during (blocks of 10-15 breaths intersperced with airway clearance physiotherapy) or post (not greater than 30 minutes post) airway clearance physiotherapy in random order.
The three inhalation regimes will be carried out over three consecutive days (no washout) at the end of a hospital admission when clinical signs have stabilised. The timing regime for that day will be performed for each airway clearance physiotherapy session. Participants will perform their usual daily number of airway clearance sessions (1-3), the same number will be performed on each of the study days. Each HS inhalation will be 4mLs (usually 15-20 minutes to deliver). Each airway clearance physiotherapy session will be 20-40 minutes with the duration for that participant similar for the three days.

A post treatment spirometry will be performed two hours post baseline spirometry each day and a VAS completed regarding ease of expectoration, tolerability and overall satisfaction for this order of inhalation and aiway clearance. The spirometry readings will be recorded with the afternoon physiotherapy treatment. Thus the pre and post spirometry readings are two hours apart at a similar time of the day on each of the study days.
Intervention code [1] 264496 0
Treatment: Drugs
Comparator / control treatment
Three arm cross over. Standard treatment is inhalation of HS pre airway clearance physiotherapy.
Control group
Active

Outcomes
Primary outcome [1] 266660 0
Lung function (FEV1, FVC) as measured by Spirometry
Timepoint [1] 266660 0
A post treatment spirometry will be performed two hours post baseline spirometry each day The spirometry readings will be recorded with the afternoon physiotherapy treatment. Thus the pre and post spirometry readings are two hours apart at a similar time of the day on each of the study days.
Primary outcome [2] 266661 0
Subjective efficacy, tolerability and overall satisfaction as measures on a VAS scale
Timepoint [2] 266661 0
Post treatment VAS scores will be performed two hours post baseline spirometry immediately prior to the post treatment spirometry each day The VAS readings will be recorded with the afternoon physiotherapy treatment. Thus the VAS readings are at a similar time of the day on each of the study days.
Secondary outcome [1] 276970 0
Nil
Timepoint [1] 276970 0
Nil

Eligibility
Key inclusion criteria
Inclusion Criteria: provides informed consent; diagnosis of CF (sweat test or genotyping); Greater than or equal to 18 yrs; FEV1 within 10% of best FEV1 in the previous 6 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria: colonisation with B. cepacia;; major hemoptysis in the preceeding month; previous lung transplant; thrombocytopaenia; pregnancy or at risk of pregnancy.

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)
Following consent, subjects will be randomised to three timing regimes of HS inhalation over three days (sequence of three interventions in sealed opaque envelopes). Each day subjects will perform baseline spirometry, inhalation of bronchodilator, and inhalation of HS (either pre, during or post airway clearance physiotherapy in random order).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent blinded researcher generated sequences of inhalation for before, during and after airway clearance for the anticipated 50 participants (power calculation) using a dice roll. The order of inhalations was then sealed in an opaque envelope prior to the studies commencement.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Participants were aware of the timing of inhalations. Assessors were blinded to the order io inhalations.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264975 0
Hospital
Name [1] 264975 0
Department of Respiratory Medicine, Royal Prince Alfred Hospital
Country [1] 264975 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital, SSWAHS
Address
Missenden Road Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 264065 0
None
Name [1] 264065 0
Nil
Address [1] 264065 0
Nil
Country [1] 264065 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266934 0
SSWAHS (RPA Zone)
Ethics committee address [1] 266934 0
Ethics committee country [1] 266934 0
Australia
Date submitted for ethics approval [1] 266934 0
Approval date [1] 266934 0
01/12/2009
Ethics approval number [1] 266934 0
Protocol No X09-0283 & HREC/09/RPAH/477

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

Contacts
Principal investigator
Name 30503 0
Address 30503 0
Country 30503 0
Phone 30503 0
Fax 30503 0
Email 30503 0
Contact person for public queries
Name 13750 0
Ruth Dentice
Address 13750 0
Department of Respiratory Medicine
Level 11 West, Missenden Road
Camperdown NSW 2050
Country 13750 0
Australia
Phone 13750 0
61 2 9515 5234
Fax 13750 0
61 2 9515 8196
Email 13750 0
[email protected]
Contact person for scientific queries
Name 4678 0
Ruth Dentice
Address 4678 0
Department of Respiratory Medicine
Level 11 West, Missenden Road
Camperdown NSW 2050
Country 4678 0
Australia
Phone 4678 0
61 2 9515 5234
Fax 4678 0
61 2 9515 8196
Email 4678 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
No additional documents have been identified.