Magnesium Nebulization Utilization in Management of Pediatric Asthma
Condition: Acute Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      The investigators plan the following specific aims:

        1. Primary Objective: To examine if in children with acute asthma remaining in moderate to
           severe respiratory distress despite maximized initial bronchodilator and steroid therapy
           there is a reduction in hospitalization rate from the ED in those who receive nebulized
           Mg with salbutamol versus those receiving salbutamol only.

           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.

        2. To compare a difference in the changes in the validated Pediatric Respiratory Assessment
           Measure (PRAM), respiratory rate, oxygen saturation and blood pressure from
           randomization baseline to 240 minutes in the two groups

        3. To determine if there is a significant association between the difference in the primary
           outcome between the groups and the patient's age, gender, baseline PRAM score, personal
           history of atopy and "viral-induced wheeze" phenotype.

      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.
    

Intervention name(s): Magnesium Sulfate Sandoz; Sodium Chloride , USP PPC
Intervention type(s): Drug; Drug
Intervention description(s): Each treatment will utilize 600 mg (1.2 mL) of Magnesium Sulfate Sandoz; Intervention: The control group will receive Sodium Chloride , USP PPC (1.2 mL hypertonic 5.5% saline with 5 mg Salbutamol - GlaxoSmithKline/Pharmascience
Other intervention name(s): Magnesium Sulfate, USP 50% PPC; Sodium Chloride for Injection USP Omega Laboratories Ltd.
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pediatric; Acute Asthma; Inhaled Magnesium