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Trial registered on ANZCTR


Registration number
ACTRN12608000167369
Ethics application status
Approved
Date submitted
27/03/2008
Date registered
4/04/2008
Date last updated
4/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to investigate the effects of nebulised magnesium in severe exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
A randomised, double-blind, parallel group, placebo-controlled study investigating the efficacy and tolerability of adjuvant nebulised magnesium therapy in conjunction with standard emergency department treatment of acute severe exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
Secondary ID [1] 273401 0
Not applicable
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 2965 0
Condition category
Condition code
Respiratory 3105 3105 0 0
Chronic obstructive pulmonary disease

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 (total dose 0.625mmol). The 3 doses are administered at time (T) = 0min, T= 30min and T = 60min. Subjects will also receive standard therapy for a severe COPD exacerbation in accordance with emergency department protocols and their clinical presentation.
Intervention code [1] 2700 0
Treatment: Drugs
Comparator / control treatment
The control is neublised isotonic saline (placebo)
Control group
Placebo

Outcomes
Primary outcome [1] 3995 0
Forced Expiratory Volume in 1 second (FEV1) in litres/minute measured by handheld spirometer
Timepoint [1] 3995 0
At 30 minutes, 60 minutes and 90 minutes
Secondary outcome [1] 6724 0
Combined endpoint of FEV1 at 90 minutes minutes and hospital admission in subjects with life-threatening COPD (FEV1 <30% predicted at randomisation)
Timepoint [1] 6724 0
90 minutes
Secondary outcome [2] 6725 0
Hospital admission
Timepoint [2] 6725 0
Measured throughout stay in the emergency department
Secondary outcome [3] 6726 0
Requirement for non-invasive or invasive ventilation.
Timepoint [3] 6726 0
Measured throughout stay in the emergency department and hospital ward if admitted
Secondary outcome [4] 6727 0
Admission to the Intensive Care Unit (ICU)
Timepoint [4] 6727 0
Measured throughout stay in the emergency department and hospital ward if admitted
Secondary outcome [5] 294868 0
Mortality at 30 days
Timepoint [5] 294868 0
Mortality will be assessed 30 days after the presentation to the Emergency Department

Eligibility
Key inclusion criteria
Aged greater than 35 years old; Doctor diagnosis of COPD, emphysema or chronic bronchitis; Presentation to the Emergency Department (ED) with a severe exacerbation of COPD (initial FEV1 < or = 50% predicted)
Minimum age
36 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients requiring intubation or non-invasive ventilation on arrival, or too unwell to perform spirometry at presentation; Another serious medical condition that would prevent their participation in the trial; Pregnant women; Pneumothorax

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
Completed
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] 826 0
New Zealand
State/province [1] 826 0

Funding & Sponsors
Funding source category [1] 3225 0
Government body
Name [1] 3225 0
Health Research Council of New Zealand
Address [1] 3225 0
PO Box 5541,
Wellesley Street,
Auckland 1141
Country [1] 3225 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
Level 7 CSB Building
Wellington Regional Hospital
Riddiford Street
Newtown
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 2888 0
None
Name [1] 2888 0
Address [1] 2888 0
Country [1] 2888 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5211 0
Central Regional Ethics Committee
Ethics committee address [1] 5211 0
Ministry of Health
Level 2, 1-3 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 5211 0
New Zealand
Date submitted for ethics approval [1] 5211 0
26/11/2007
Approval date [1] 5211 0
15/02/2008
Ethics approval number [1] 5211 0
CEN/07/12/087

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

Contacts
Principal investigator
Name 28468 0
Address 28468 0
Country 28468 0
Phone 28468 0
Fax 28468 0
Email 28468 0
Contact person for public queries
Name 11625 0
Dr Kyle Perrin
Address 11625 0
Medical Research Institute of New Zealand
Level 7 CSB Building
Wellington Regional Hospital
Wellington 6021
Country 11625 0
New Zealand
Phone 11625 0
+64 4 805 0147
Fax 11625 0
Email 11625 0
kyle.perrin@mrinz.ac.nz
Contact person for scientific queries
Name 2553 0
Dr Kyle Perrin
Address 2553 0
Medical Research Institute of New Zealand
Level 7 CSB Building
Wellington Regional Hospital
Wellington 6021
Country 2553 0
New Zealand
Phone 2553 0
+64 4 805 0147
Fax 2553 0
Email 2553 0
kyle.perrin@mrinz.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary