A randomised, placebo-controlled study of nebulised magnesium in acute severe asthma in children
| ISRCTN | ISRCTN81456894 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81456894 |
| Secondary identifying numbers | HTA 05/503/10 |
- Submission date
- 05/11/2007
- Registration date
- 15/11/2007
- Last edited
- 24/07/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
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
Contact information
Scientific
Department of Paediatrics
University Hospital of Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom
| Phone | +44 (0)29 2074 7747 |
|---|---|
| colin.powell@cardiffandvale.wales.nhs.uk |
Study information
| Study design | Multicentre randomised placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised, placebo-controlled study of nebulised magnesium in acute severe asthma in children |
| Study 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(s) | North West Research Ethics Committee, 18/02/2008, ref: 07/H1010/101 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Magnesium, salbutamol, ipratropium bromide |
| Primary outcome measure | 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 childs illness) |
| Overall study start date | 01/12/2007 |
| Overall study end date | 25/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Sex | Both |
| Target number of participants | 500 |
| 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 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
- Wales
Study participating centre
CF14 4XW
United Kingdom
Sponsor information
University/education
Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom
| Phone | +44 (0)29 2087 9274 |
|---|---|
| davieskp2@cardiff.ac.uk | |
| Website | http://www.cf.ac.uk |
"ROR" |
https://ror.org/03kk7td41 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2013 | Yes | No | |
| Results article | results | 01/10/2013 | Yes | No | |
| Results article | results | 23/12/2016 | Yes | No |
Editorial Notes
24/07/2019: The overall trial end date has been changed from 30/11/2010 to 25/10/2011.
29/12/2016: Publication reference added.
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.
