Magnesium Sulfate Sandoz
DrugEach treatment will utilize 600 mg (1.2 mL) of Magnesium Sulfate Sandoz
Other names: Magnesium Sulfate, USP 50% PPC
NCT Number: NCT01429415
Acute asthma is the most common cause of pediatric hospitalizations. While the investigators know that repeat inhalations of ß2 agonists and ipratropium with early oral steroids substantially reduce hospitalizations, many children are resistant to this standard initial therapy. About a third of children remaining in moderate to severe distress after standard therapy are admitted to hospital and comprise 84% of pediatric acute asthma hospitalizations. Finding safe, non-invasive, and effective strategies to treat children resistant to standard therapy would substantially decrease hospitalizations resulting in considerable health care savings and reduction of the psycho-social burden of the disease. While studies of magnesium sulfate (Mg) given intravenously (IV) suggest that this agent can reduce hospitalizations in both adults and children resistant to standard initial therapy Nebulization is an alternate route for administering Mg. This route has the advantage of being non-invasive and is likely much safer due to lower systemic delivery. Direct delivery via nebulization allows higher Mg concentrations at the target site, the lower airways, with a smaller total drug dose. The investigators propose to conduct a properly designed study to clarify the role of nebulized Mg.
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Notify Me2 year–17 year
All sexes
Interventional
Phase 2
Alberta Children's Hospital, Calgary, Alberta, Canada
The investigators plan the following specific aims:
Hypothesis: The investigators hypothesize that the children with Pediatric Respiratory Assessment Measure (PRAM) ≥ 5 points after optimized initial inhaled bronchodilator and oral steroid therapies who are given nebulized Mg in addition to nebulized salbutamol will have significantly lower hospitalization rate within 24 hours of starting the study compared to those given salbutamol only.
Hypothesis(es) to be Tested In this randomized, double-blind seven-centre trial, the investigators hypothesize that children with acute asthma with a Pediatric Respiratory Assessment Measure (PRAM) of ≥ 5 points after optimized initial inhaled bronchodilator and oral steroid therapies who are given nebulized Mg in addition to nebulized salbutamol will have at least a 10% lower hospitalization rate within 24 hours of starting the study as compared to those given salbutamol only.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each treatment will utilize 600 mg (1.2 mL) of Magnesium Sulfate Sandoz
Other names: Magnesium Sulfate, USP 50% PPC
Intervention: The control group will receive Sodium Chloride , USP PPC (1.2 mL hypertonic 5.5% saline with 5 mg Salbutamol - GlaxoSmithKline/Pharmascience
Other names: Sodium Chloride for Injection USP Omega Laboratories Ltd.
Time frame: Up to 24 hours after treatment
Defined as admission to an inpatient unit within 24hours of the start of experimental therapy due to continued/worsening distress.
Time frame: 0, 20, 40 60, 120, 180, 240 minutes post dose
PRAM is a validated measure of asthma severity in the Emergency Department
Time frame: 0, 20, 40, 60, 120, 180, 240 minutes post dose
Respiratory Rate, O2 saturation, Blood pressure
Time frame: Up to 240 minutes post dose
This measure of additional therapy may strengthen the measure of benefit of inhaled magnesium
Time frame: Baseline
The investigators will measure hospitalization and age, gender, pre-randomization PRAM score, personal history of atopy, and "acute viral induced wheeze" phenotype. This phenotype will be defined by age less than 5 years, co-existent upper respiratory tract infection, no interval symptoms between exacerbations, no atopy
The Hospital for Sick Children
Other
Acronym: MAGNUMPA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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