Condition category
Respiratory
Date applied
05/11/2007
Date assigned
15/11/2007
Last edited
12/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Asthma is a common long-term condition that can cause coughing, wheezing, chest tightness and breathlessness. There is uncertainty in the management of acute asthma, with major differences between the management of children and adults. Adults are given magnesium intravenously (into a vein) early in the treatment of an acute asthma attack, but this is not recommended in children. Although magnesium is very safe when given intravenously, there is a need to monitor blood levels. A recent study in adults has demonstrated a good effect for magnesium given via a nebuliser (a machine that delivers medication by turning it into a mist to be inhaled through a face mask or mouthpiece). The aim of this study is to determine whether nebulised magnesium is useful in the treatment of acute asthma in childhood. Currently, the next step in the guidelines would be to commence intravenous treatment with medication to dilate (open up) the airways. If children respond to nebulised magnesium at this stage they may not need to go on to have a canula (needle) placed in the vein for more intensive treatment.

Who can participate?
Children aged 2-16 with severe acute asthma

What does the study involve?
When the child attends either a hospital emergency department or an emergency paediatric unit, if they do not respond to the standard treatment in the first 20 minutes, then they are randomly allocated to receive nebulised salbutamol and ipratropium bromide mixed with either magnesium sulphate or saline (dummy drug) on three occasions at 20-minute intervals. They are closely monitored over the following four hours.

What are the possible benefits and risks of participating?
There are few side effects from magnesium, none described for inhaled magnesium, but these will be monitored by an independent committee.

Where is the study run from?
University Hospital of Wales (UK)

When is the study starting and how long is it expected to run for?
December 2007 to November 2010

Who is funding the study?
Health Technology Assessment Programme (UK)

Who is the main contact?
Dr Colin Powell
colin.powell@cardiffandvale.wales.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Colin Powell

ORCID ID

Contact details

Department of Paediatrics
University Hospital of Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom
+44 (0)29 2074 7747
colin.powell@cardiffandvale.wales.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 05/503/10

Study information

Scientific title

A randomised, placebo-controlled study of nebulised magnesium in acute severe asthma in children

Acronym

MAGNETIC

Study hypothesis

Does nebulised magnesium used as an adjunct to nebulised salbutamol and ipratropium bromide for one hour in children with severe asthma result in a clinical improvement when compared to nebulsied salbutamol, ipratropium bromide and placebo?

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/0550310
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0017/51218/PRO-05-503-10.pdf

Ethics approval

North West Research Ethics Committee, 18/02/2008, ref: 07/H1010/101

Study design

Multicentre randomised placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Severe exacerbation of asthma

Intervention

Children aged 2 - 5 years will be randomised to receive nebulised salbutamol 2.5 mg and ipratropium bromide 0.25 mg mixed with either 2.5 ml of isotonic magnesium sulphate (250 mmol/L, tonicity 289 mOsm; 151 mg per dose) or 2.5 ml of isotonic saline on three occasions at twenty-minute intervals. Children 6 years and over will receive 5 mg of nebulised salbutamol.

Total duration of follow-up is one month.

Intervention type

Drug

Phase

Not Applicable

Drug names

Magnesium, salbutamol, ipratropium bromide

Primary outcome measures

The Yung Asthma Severity Score (ASS) after 60 minutes of treatment

Secondary outcome measures

Clinical (during hospitalisation):
1. ‘Stepping down’ of treatment at one hour i.e. changed to having hourly treatment after the initial three, twenty-minute nebulisers
2. Number and frequency of additional salbutamol
3. Length of stay in hospital
4. Requirement for intravenous bronchodilator treatment
5. Intubation and/or admission to a Paediatric Intensive Care Unit (PICU)

Patient outcomes at follow-up (1 month):
1. Paediatric Quality of Life Inventory (PedsQL™) asthma module parental report for all children and self-completion if aged over 5 years, European Quality of Life questionnaire (EQ-5D)
2. Time off school/nursery
3. Health care resource usage (e.g. General Practitioner [GP] visits, additional prescribing)

Parent outcomes at follow-up (1 month):
1. Time off work (related to child’s illness)

Overall trial start date

01/12/2007

Overall trial end date

30/11/2010

Reason abandoned

Eligibility

Participant inclusion criteria

For children 6 years and older severe asthma is based on at least one of the following criteria being met:
1. Oxygen saturations less than 92% while breathing room air
2. Too breathless to talk
3. Heart rate greater than 120/min
4. Respiratory rate greater than 30/min
5. Use of accessory neck muscles

For children aged 2 - 5 years of age, severe asthma is based on at least one of the following criteria being met:
1. Oxygen saturations less than 92% while breathing room air
2. Too breathless to talk
3. Heart rate greater than 130/min
4. Respiratory rate greater than 50/min
5. Use of accessory neck muscles

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

500

Participant exclusion criteria

1. Coexisting respiratory disease such as cystic fibrosis, chronic lung disease of prematurity
2. Severe renal disease
3. Severe liver disease
4. Known to be pregnant
5. Known to have had a reaction to magnesium previously
6. Parents who are unable to give informed consent
7. Previously randomised into MAGNETIC trial
8. Patients who present with life threatening symptoms
9. Previously involved with a trial of a medicinal product in the three months preceding screening

Recruitment start date

01/12/2007

Recruitment end date

30/11/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital of Wales
Cardiff
CF14 4XW
United Kingdom

Sponsor information

Organisation

Cardiff University (UK)

Sponsor details

Newport Road
Cardiff
CF24 0DE
United Kingdom
+44 (0)29 2087 9274
davieskp2@cardiff.ac.uk

Sponsor type

University/education

Website

http://www.cf.ac.uk

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24429155
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24144222

Publication citations

  1. Results

    Powell C, Kolamunnage-Dona R, Lowe J, Boland A, Petrou S, Doull I, Hood K, Williamson P, , Magnesium sulphate in acute severe asthma in children (MAGNETIC): a randomised, placebo-controlled trial., Lancet Respir Med, 2013, 1, 4, 301-308, doi: 10.1016/S2213-2600(13)70037-7.

  2. Results

    Powell CV, Kolamunnage-Dona R, Lowe J, Boland A, Petrou S, Doull I, Hood K, Williamson PR, , MAGNEsium Trial In Children (MAGNETIC): a randomised, placebo-controlled trial and economic evaluation of nebulised magnesium sulphate in acute severe asthma in children., Health Technol Assess, 2013, 17, 45, v-vi, 1-216, doi: 10.3310/hta17450.

Additional files

Editorial Notes

11/05/2009: the following changes were made to the trial record: 1. The overall trial start and end dates were changed from 01/03/2008 and 01/03/2010 to 01/12/2007 and 30/11/2010, respectively. 2. The HTA grant number has been changed from HTA 02/503/10 to HTA 05/503/10.