Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000038291
Ethics application status
Approved
Date submitted
28/11/2008
Date registered
19/01/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to investigate the effects of nebulised magnesium in severe exacerbations of asthma
Scientific title
A randomized, double-blind, parallel group, placebo-controlled study investigating the efficacy and tolerability of nebulised salbutamol in magnesium adjuvant in the management of acute severe asthma
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute asthma 4042 0
Condition category
Condition code
Respiratory 4245 4245 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment intervention is 2.5mL of 0.25mmol/mL magnesium sulphate solution given as a nebulised inhalation on 3 occasions, at time (T) = 0min, T = 30min and T = 60min.
Intervention code [1] 3762 0
Treatment: Drugs
Comparator / control treatment
The control is 2.5mL of isotonic saline (placebo) given as a nebulised inhalation on 3 occasions, at time (T) = 0min, T = 30min and T = 60min.
Control group
Placebo

Outcomes
Primary outcome [1] 5131 0
Forced Expiratory Volume in 1 second (FEV1) in litres/minute measured by handheld spirometer
Timepoint [1] 5131 0
30, 60 and 90 minutes after the first administration of nebulised magnesium sulphate or placebo.
Secondary outcome [1] 8636 0
Hospital admission
Timepoint [1] 8636 0
Measured throughout stay in the emergency department
Secondary outcome [2] 8637 0
Intensive care unit admission
Timepoint [2] 8637 0
Measured throughout stay in the emergency department and hospital ward if admitted
Secondary outcome [3] 8638 0
Combined endpoint of FEV1 at 90 minutes minutes and hospital admission in subjects with life-threatening asthma (FEV1 <30% predicted at randomisation)
Timepoint [3] 8638 0
90 minutes after the first administration of nebulised magnesium sulphate or placebo.
Secondary outcome [4] 8639 0
Need for escalation in pharmacological treatment [intravenous (IV) magnesium, IV salbutamol or IV theophylline]
Timepoint [4] 8639 0
Measured throughout stay in the emergency department

Eligibility
Key inclusion criteria
Aged between 16 and 65 years; Doctor diagnosis of asthma; Presentation to the Emergency Department (ED) with a severe exacerbation of asthma (initial FEV1 < or = 50% predicted)
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients requiring intubation or too unwell to perform spirometry on at presentation; Known cardiac disease, chronic renal insufficiency or another serious medical condition that would prevent their participation in the trial; Pregnant women; Pneumothorax or pneumonia; Previously documented chronic airflow limitation with fixed airways obstruction.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
8/12/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 1420 0
New Zealand
State/province [1] 1420 0

Funding & Sponsors
Funding source category [1] 4221 0
Government body
Name [1] 4221 0
Health Research Council of New Zealand
Country [1] 4221 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
3rd Floor,
99 The Terrace,
PO Box 10055
Wellington 6143
Country
New Zealand
Secondary sponsor category [1] 3795 0
None
Name [1] 3795 0
Address [1] 3795 0
Country [1] 3795 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6276 0
Central Regional Ethics Committee
Ethics committee address [1] 6276 0
Ministry of Health,
Level 2, 1-3 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 6276 0
New Zealand
Date submitted for ethics approval [1] 6276 0
Approval date [1] 6276 0
Ethics approval number [1] 6276 0

Summary
Brief summary
The mineral magnesium has been shown to be safe and effective in the treatment of severe asthma when given intravenously (directly into the blood); however, only limited research has been conducted to find out the effect of magnesium given via nebuliser so that it can be inhaled by patients with severe exacerbations of asthma. A nebuliser is a machine that turns liquid medication into vapour so that it can be inhaled (breathed in). It is thought that giving the magnesium by the nebuliser might reduce the risk of side effects compared with giving it intravenously. In this study the magnesium will be given using a nebuliser along with a medication called salbutamol which is commonly used to treat asthma. The study will compare the effectiveness and safety of giving magnesium this way with giving the standard treatment of salbutamol alone in people having a severe asthma attack.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29177 0
Address 29177 0
Country 29177 0
Phone 29177 0
Fax 29177 0
Email 29177 0
Contact person for public queries
Name 12334 0
Dr Kyle Perrin
Address 12334 0
Medical Research Institute of New Zealand
PO Box 10055
The Terrace
Wellington 6143
Country 12334 0
New Zealand
Phone 12334 0
+64 4 472 9199
Fax 12334 0
Email 12334 0
[email protected]
Contact person for scientific queries
Name 3262 0
Dr Kyle Perrin
Address 3262 0
Medical Research Institute of New Zealand
PO Box 10055
The Terrace
Wellington 6143
Country 3262 0
New Zealand
Phone 3262 0
+64 4 472 9199
Fax 3262 0
Email 3262 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
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