Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000400268
Ethics application status
Approved
Date submitted
6/03/2018
Date registered
20/03/2018
Date last updated
27/09/2023
Date data sharing statement initially provided
25/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing high versus low dose of nebulised salbutamol in acute adult asthmatics presenting to the Emergency Department.
Scientific title
A non-inferiority comparison of low versus high salbutamol dosing regimens via nebusliser in severe to life-threatening exacerbations of adult asthmatics presenting to the emergency department: A randomised controlled trial.
Secondary ID [1] 294243 0
None
Universal Trial Number (UTN)
U1111-1210-2885
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 306922 0
Condition category
Condition code
Emergency medicine 306019 306019 0 0
Other emergency care
Respiratory 306076 306076 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
5mg salbutamol nebulisation every 20minutes over 1 hour. This will be directly observed by the investigator.
Intervention code [1] 300540 0
Treatment: Drugs
Comparator / control treatment
2.5mg salbutamol nebulisation every 20minutes over 1 hour.T his will be directly observed by the investigator.
Control group
Dose comparison

Outcomes
Primary outcome [1] 305053 0
FEV1 using bedside handheld spirometry.
Timepoint [1] 305053 0
At 60minutes post treatment protocol commencement,
Secondary outcome [1] 344001 0
FEV1 using bedside handheld spirometry.
Timepoint [1] 344001 0
At 20 and 40 minutes post treatment protocol commencement
Secondary outcome [2] 344191 0
Total dose of salbutamol administered at 120minutes post commencement of treatment protocol. This will be recorded by the attending clinician on the trial proforma.
Timepoint [2] 344191 0
120minutes post commencement of treatment protocol
Secondary outcome [3] 344192 0
Length of stay in ED. This will be monitored by the investigator.
Timepoint [3] 344192 0
When patient leaves the Emergency Department for another inpatient location or discharge from hospital.
Secondary outcome [4] 344193 0
Treatment failure defined as the need for non-invasive or invasive ventilation and IV salbutamol. This will be recorded by the investigator.
Timepoint [4] 344193 0
60minutes post commencement of treatment protocol
Secondary outcome [5] 344194 0
Adverse events: symptoms mirroring salbutamol toxicity, such as tremor, anxiety, uncharacteristic tachycardia or tachypnoea. These measures will be identified by the treating clinician and recorded by the investigator.
Timepoint [5] 344194 0
At 60minutes after commencement of the treatment protocol.

Eligibility
Key inclusion criteria
• Doctor diagnosis of asthma
• Age 18 to 65 years
• Presentation to ED with a severe asthma exacerbation
• PEF < 50% 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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Inability to perform spirometry
• Requirement for Non-invasive ventilation (NIV) or intubation at presentation
• 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)
Allocation by computer generation to either trial drug A or B. Nebules will be masked by re-labeling the nebules either trial drug A or B. Masking will be carried out by the Pharmacy Department. The Investigators will not know what dose nebules 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
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Safety concerns
Date of first participant enrolment
Anticipated
3/06/2019
Actual
16/07/2019
Date of last participant enrolment
Anticipated
30/06/2021
Actual
14/02/2021
Date of last data collection
Anticipated
12/07/2021
Actual
14/02/2021
Sample size
Target
148
Accrual to date
Final
27
Recruitment outside Australia
Country [1] 9651 0
New Zealand
State/province [1] 9651 0
Wellington

Funding & Sponsors
Funding source category [1] 298882 0
Other
Name [1] 298882 0
Medical Research Institute of New Zealand
Country [1] 298882 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] 298095 0
None
Name [1] 298095 0
Address [1] 298095 0
Country [1] 298095 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299824 0
Health and Disability Ethics Comission
Ethics committee address [1] 299824 0
Ethics committee country [1] 299824 0
New Zealand
Date submitted for ethics approval [1] 299824 0
22/03/2018
Approval date [1] 299824 0
02/04/2018
Ethics approval number [1] 299824 0

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

Contacts
Principal investigator
Name 81682 0
Dr Saptarshi Mukerji
Address 81682 0
Emergency Department, Capital and Coast District Health Board 23 Mein Street Newtown Wellington 6021
Country 81682 0
New Zealand
Phone 81682 0
+64223128766
Fax 81682 0
Email 81682 0
[email protected]
Contact person for public queries
Name 81683 0
Saptarshi Mukerji
Address 81683 0
Emergency Department, Capital and Coast District Health Board 23 Mein Street Newtown Wellington 6021
Country 81683 0
New Zealand
Phone 81683 0
+64223128766
Fax 81683 0
Email 81683 0
[email protected]
Contact person for scientific queries
Name 81684 0
Saptarshi Mukerji
Address 81684 0
Emergency Department, Capital and Coast District Health Board 23 Mein Street Newtown Wellington 6021
Country 81684 0
New Zealand
Phone 81684 0
+64223128766
Fax 81684 0
Email 81684 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Available to appropriate institutions or individuals, who have appropriate clearances.

Conditions for requesting access:
• -

What individual participant data might be shared?
• All data de-identified

What types of analyses could be done with individual participant data?
• Any

When can requests for individual participant data be made (start and end dates)?
From:
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 December 2021 for a 12 month period.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Data will be electronic and can be shared on request.

Are there extra considerations when requesting access to individual participant data?
No


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.