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Trial registered on ANZCTR


Registration number
ACTRN12618000397213p
Ethics application status
Not yet submitted
Date submitted
6/03/2018
Date registered
20/03/2018
Date last updated
25/02/2019
Date data sharing statement initially provided
25/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of high dose versus low dose salbutamol in acute adult asthmatics presenting to the Emergency Department.
Scientific title
A non-inferiority comparison of low versus high salbutamol dosing regimens via MDI in mild to moderate exacerbations of asthma in adults presenting to the emergency department: a randomized controlled trial.
Secondary ID [1] 294232 0
None
Universal Trial Number (UTN)
U1111-1210-2845
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
asthma 306920 0
Condition category
Condition code
Emergency medicine 306017 306017 0 0
Other emergency care
Respiratory 306077 306077 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Salbutamol administered via 100mcg actuation MDI and spacer. 10 puffs every 20minutes over 1 hour. This will be monitored by the trial investigator.
Intervention code [1] 300536 0
Treatment: Drugs
Comparator / control treatment
Salbutamol 100mcg actuation MDIs- 5 puffs and Placebo MDI 5 puffs. Both inhalers will be delivered using a spacer. This will be directly observed by the trial investigator.
Control group
Dose comparison

Outcomes
Primary outcome [1] 305051 0
FEV1, using bedside, handheld spirometry.
Timepoint [1] 305051 0
60 minutes post treatment protocol commencement.
Secondary outcome [1] 343996 0
FEV1 using bedside, handheld spirometry.
Timepoint [1] 343996 0
At 20 and 40 minutes post treatment protocol commencement.
Secondary outcome [2] 344195 0
Length of stay in the Emergency Department, monitored by the investigator
Timepoint [2] 344195 0
At time of discharge from the ED either to an inpatient location or home.
Secondary outcome [3] 344196 0
Proportion of patient admitted to hospital, recorded by the investigator
Timepoint [3] 344196 0
At time of discharge from the ED
Secondary outcome [4] 344197 0
Treatment failure, defined as the need for non-invasive ventilation, IV salbutamol and the need for nebulised bronchodilator therapies.
Timepoint [4] 344197 0
at 60minutes post treatment protocol commencement.
Secondary outcome [5] 344198 0
Adverse events: symptoms mirroring those of salbutamol toxicity, such as tremor, anxiety, uncharacteristic tachycardia and tachypnoea. These will be identified by the attending clinician and recorded on the trial proforma
Timepoint [5] 344198 0
At 60minutes after the commencement of the treatment protocol.

Eligibility
Key inclusion criteria
• Doctor diagnosis of asthma
• Age 18 to 65 years
• Presentation to ED with a mild- moderate asthma exacerbation
• PEF 50 to 75% of predicted
• Concomitant asthma medication may include: none, ICS, ICS/LABA, theophylline, LTRA, oral steroids, sodium cromoglycate, nedocromil sodium
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Inability to perform spirometry
• Requirement for Non-invasive ventilation (NIV) or intubation
• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)

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)
Electronic randomisation using a tablet at the bedside. Allocation to either trial drug A or B. MDI canisters will be masked and re-labeled as trial drug A or B by the Pharmacy department. The investigators will not know what drugs A and B are.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised 1:1 using a computer generated block randomisation sequence provided by the study biostatistician, incorporated into the electronic data capture system.
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
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The statistical analysis will be by both intention to treat and per protocol by a biostatistician blinded to allocation. The primary outcome variable will be FEV1 measured after 60 minutes. The primary analysis will be ANCOVA with adjustment for baseline FEV1. Secondary outcomes will be FEV1, heart rate, respiratory rate and SpO2 at each time point, the total amount of nebulised salbutamol used in the first 2 hours, time in the ED, hospital admission, treatment failure (defined by the need for any of intravenous salbutamol, invasive or non-invasive ventilation, or ICU admission) and adverse events.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9650 0
New Zealand
State/province [1] 9650 0
Wellington

Funding & Sponsors
Funding source category [1] 298871 0
Other
Name [1] 298871 0
Medical Research Institute of New Zealand
Address [1] 298871 0
Private Bag 7902
Wellington 6242

Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
New Zealand
Country [1] 298871 0
New Zealand
Primary sponsor type
Other
Name
Medical Research Institute of New Zealand
Address
Private Bag 7902
Wellington 6242

Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
New Zealand
Country
New Zealand
Secondary sponsor category [1] 298078 0
None
Name [1] 298078 0
Address [1] 298078 0
Country [1] 298078 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 299812 0
Health and Disability Ethics Comission
Ethics committee address [1] 299812 0
Postal address:
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 299812 0
New Zealand
Date submitted for ethics approval [1] 299812 0
15/03/2018
Approval date [1] 299812 0
Ethics approval number [1] 299812 0

Summary
Brief summary
Despite extensive standard practice of the use of salbutamol in the treatment of acute asthma exacerbations, it is unclear how much should be given. This ambiguity has led clinicians to often give more than required salbutamol doses due to a perceived better outcome with higher doses. This can lead to multiple unpleasant side effects and reduces the tolerability of the treatment amongst patient groups.
We are carrying out a blinded randomised controlled trial to compare a higher dose against a lower dose of salbutamol in acute asthma presentations to the emergency department. We aim to compare several outcomes in both groups, including improvement in lung function, length of hospital stay, rates of admission to hospital and adverse events.
This is a non-inferiority study and we hypothesise that there will be no difference in outcome in both groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81642 0
Dr Saptarshi Mukerji
Address 81642 0
Emergency Department, Capital and Coast District Health Board
23 Mein Street
Newtown
Wellington
6021
Country 81642 0
New Zealand
Phone 81642 0
+64223128766
Fax 81642 0
Email 81642 0
sapimuk09@gmail.com
Contact person for public queries
Name 81643 0
Dr Saptarshi Mukerji
Address 81643 0
Emergency Department, Capital and Coast District Health Board
23 Mein Street
Newtown
Wellington
6021
Country 81643 0
New Zealand
Phone 81643 0
+64223128766
Fax 81643 0
Email 81643 0
sapimuk09@gmail.com
Contact person for scientific queries
Name 81644 0
Dr Saptarshi Mukerji
Address 81644 0
Emergency Department, Capital and Coast District Health Board
23 Mein Street
Newtown
Wellington
6021
Country 81644 0
New Zealand
Phone 81644 0
+64223128766
Fax 81644 0
Email 81644 0
sapimuk09@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data de-identified
When will data be available (start and end dates)?
After publication of results in peer reviewed journal. It is unclear at this early time point how long it would take to publish results. However, at an estimate data may be made available from June 2021 for a 12 month period.
Available to whom?
Available to appropriate institutions or individuals, who have appropriate clearances.
Available for what types of analyses?
Any
How or where can data be obtained?
Data will be electronic and can be shared on request.
What supporting documents are/will be available?
No other documents available
Summary results
No Results