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A randomised, placebo controlled study of nebulised magnesium in acute severe asthma in children
ISRCTN ISRCTN81456894
DOI 10.1186/ISRCTN81456894
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised, placebo controlled study of nebulised magnesium in acute severe asthma in children
Scientific title
Acronym MAGNETIC
Serial number at source HTA 05/503/10
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?

Please note that, as of 11/05/2009, the following amendments have been made to this ISRCTN record:
1. The anticipated start and end dates have been updated 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.
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from the North West Research Ethics Committee on the 18th February 2008 (ref: 07/H1010/101).
Study design A multicentre, randomised, placebo controlled study of nebulised magnesium in acute severe asthma in children.
Countries of recruitment United Kingdom
Disease/condition/study domain Severe exacerbation of asthma
Participants - 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
Participants - 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
Anticipated start date 01/12/2007
Anticipated end date 30/11/2010
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 500
Interventions 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.
Primary outcome measure(s) The Yung Asthma Severity Score (ASS) after 60 minutes of treatment.
Secondary outcome measure(s) 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)
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24429155
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24144222
Contact name Dr  Colin  Powell
  Address Department of Paediatrics
University Hospital of Wales
Heath Park
  City/town Cardiff
  Zip/Postcode CF14 4XW
  Country United Kingdom
  Tel +44 (0)29 2074 7747
  Fax +44 (0)29 2074 4822
  Email colin.powell@cardiffandvale.wales.nhs.uk
Sponsor Cardiff University (UK)
  Address Newport Road
  City/town Cardiff
  Zip/Postcode CF24 0DE
  Country United Kingdom
  Tel +44 (0)29 2087 9274
  Fax +44 (0)29 2087 9280
  Email davieskp2@cardiff.ac.uk
  Sponsor website: http://www.cf.ac.uk
Date applied 05/11/2007
Last edited 03/06/2014
Date ISRCTN assigned 15/11/2007
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