E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
MAGNET is a randomised placebo(isotonic saline) controlled trial of the use of nebulised magnesium sulphate in moderate/severe acute asthma in childhood. All children (2-16 years of age) presenting to the paediatric assessment unit or the emergency unit at the University Hospital of Wales with severe asthma will be eligible for the study. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
1) To determine the number of children presenting with poorly responsive asthma to a large University teaching Hospital 2) To determine wether nebulised magnesium sulphate has any benefit when added to nebulised salbutamol and ipratropium in this population |
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E.2.2 | Secondary objectives of the trial |
MAGNET will act as a pilot study to guide the design of a larger multicentre study. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
. Severe asthma will be defined as per the BTS /SIGN guideline. For children 5 years and older severe asthma is based on one of the following criteria being met 1) oxygen saturations less than 93% while breathing room air 2) Peak expiratory flow (PEF) less than 50% best or predicted 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 one of the following criteria being met 1) oxygen saturations less than 93% while breathing room air 2) Too breathless to talk or eat 3) Heart rate greater than 130/min 4) Respiratory rate greater than 50/min 5) Use of accessory neck muscles. Management will be as per the guideline with inhaled (or nebulised) β2 agonists, nebulised ipratropium and systemic corticosteroids. After 20 minutes of therapy, all children will have their oxygen saturations measured while breathing room air. All children with oxygen saturations of less than 93% will be invited into the study. |
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E.4 | Principal exclusion criteria |
Coexisting respiratory disease such as cystic fibrosis, chronic lung disease of prematurity, severe renal disease, severe liver disease, known to be pregnant. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The principal outcome measure will be the mean slope of the improvement of the Asthma severity score (ASS)[Conway]. The score has been validated as a measure of asthma severity in children, has been demonstrated to be re-produceable and reliable [Bishop] with good inter-observer agreement and correlates well with oxygen saturations and FEV1 [Yung]. Additional measures will include number and frequency of additional salbutamol, PEF (if old enough to perform reliably) and length of stay in hospital. Clinical assessment will be performed at entry and at 20 minutes (randomisation), 40, 60, 80, 120, 180 and 240 minutes |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The duration of hospital stay will be calculated, and 4 weeks after the acute asthma admission the research nurse will telephone the family to determine the effect of the acute episode on the child and family |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |