Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000828224
Ethics application status
Approved
Date submitted
15/09/2009
Date registered
22/09/2009
Date last updated
12/11/2018
Date data sharing statement initially provided
12/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of bronchodilators in people with recently acquired spinal cord injury
Scientific title
Effect of bronchodilators on respiratory function of people with recently acquired spinal cord injury
Secondary ID [1] 251854 0
bronchodilators in acute sci
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute spinal cord injury and effects of bronchodilators on spirometry measures 2032 0
Condition category
Condition code
Respiratory 2122 2122 0 0
Other respiratory disorders / diseases
Respiratory 2123 2123 0 0
Asthma
Neurological 2628 2628 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects in the treatment group will receive 4 puffs of salbutamol (ventolin)via a spacer. Subjects in the control group will 4 puffs of placebo salbutamol administered in the same way. Both the salbutamol(ventolin) and placebo will be administered with subjects in lying using a fspacer Subjects will not be told whether they are receiving the experimental or sham condition .Within the next week experimental subjects will receive the placebo and control subjects will receive the salbutamol (ventolin) using the same procedure as outline above. In this way, subjects will act as their own controls.Minimum wash out period will be 48 hours.
Response to ventolin and placebo will be measured using spirometry and will be compared to a baseline measure of no intervention.
Intervention code [1] 1894 0
Treatment: Drugs
Comparator / control treatment
placebo ventolin inhaler containing prolpellant only
Control group
Placebo

Outcomes
Primary outcome [1] 2960 0
Change in Peak expiratory flow and Forced expiratory volume 1 and Forced Vital Capacity with salbutamol compared to placebo
Timepoint [1] 2960 0
10 minutes post treatment
Primary outcome [2] 3537 0
spirometry (Peak expiratory flow and Forced expiratory volume 1 and Forced Vital Capacity )
Timepoint [2] 3537 0
spirometry 30 minutes post administration
Secondary outcome [1] 5009 0
response to ventolin and placebo over 30 minutes measured with spirometry. Patients will be required to perform a forced vital capacity manouvere in supine prior to and then at 10 minutes 30 minutes post administration of ventolin or placebo. Best of three attempts will be taken.
Timepoint [1] 5009 0
10 minutes and 1 hour post administration

Eligibility
Key inclusion criteria
People with tetraplegia or paraplegia above T4 acquired within 6 weeks of randomisation
Motor complete lesion (ie, American Spinal Injuries Association (ASIA)scale A or B with no zones of partial motor preservation)
Able to provide informed consent
No recent pre morbid history of asthma or premorbid use of bronchodilators
not ventilated
stable Vital capacity over preceeding 2 days OR stable respiratory status
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not medically stable, requiring ventilatory support with mechanical ventilation via endothracheal tube or tracheostomy
Premorbid recent history of asthma or bronchodilator use

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)
All patients with recently acquired Spinla Cord Injury admitted to the Royal North Shore Hospital will be screened for inclusion.The random allocation will be performed by a person independent to the study and stored off site in opaque sealed sequentially numbered envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Those eligible who provide consent will be randomly allocated to treatment or placebo group .Randomisation performed through random number allocation. Subjects will be allocated after collecting initial data.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/09/2009
Actual
30/09/2011
Date of last participant enrolment
Anticipated
Actual
23/11/2011
Date of last data collection
Anticipated
Actual
23/11/2011
Sample size
Target
20
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237566 0
Self funded/Unfunded
Name [1] 237566 0
Country [1] 237566 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital Spinal Research Fund
Address
spinal injuries unit
Royal North Shore Hospital
pacific Hwy St Leonards
NSW
2065
Country
Australia
Secondary sponsor category [1] 237127 0
None
Name [1] 237127 0
Address [1] 237127 0
Country [1] 237127 0
Other collaborator category [1] 835 0
University
Name [1] 835 0
University of Sydney
Address [1] 835 0
University of Sydney
Sydney
NSW Australia
2008
Country [1] 835 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243858 0
Northern sydney health Human research and Ethics committe
Ethics committee address [1] 243858 0
Research Building
RNSH
Pacific Hwy
St Leonards
2065
Ethics committee country [1] 243858 0
Australia
Date submitted for ethics approval [1] 243858 0
Approval date [1] 243858 0
20/03/2008
Ethics approval number [1] 243858 0
0807-140M

Summary
Brief summary
Effect of ventolin vs placebo in acute tetraplegic patients. Spirometric outcome measures
Trial website
Trial related presentations / publications
https://www.nature.com/articles/sc201262
Public notes

Contacts
Principal investigator
Name 27708 0
Mr Damien Barratt
Address 27708 0
level 7 spinal injuries unit
Pacific HWY
st Leonards
RNSH
NSW
2008
Country 27708 0
Australia
Phone 27708 0
+6194632732
Fax 27708 0
Email 27708 0
[email protected]
Contact person for public queries
Name 11083 0
Damien Barratt
Address 11083 0
Physiotherapy dept
Spinal Injuries Unit
RNSH
Pacific Hwy
St Leonards NSW 2065
Country 11083 0
Australia
Phone 11083 0
+612 8399 2102
Fax 11083 0
Email 11083 0
[email protected]
Contact person for scientific queries
Name 2011 0
Damien Barratt
Address 2011 0
Physiotherapy dept
Spinal Injuries Unit
RNSH
Pacific Hwy
St Leonards NSW 2065
Country 2011 0
Australia
Phone 2011 0
+612 8399 2102
Fax 2011 0
Email 2011 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
No additional documents have been identified.