Magnesium Nebulization Utilization in Management of Pediatric Asthma (MAGNUMPA)
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ClinicalTrials.gov Identifier: NCT01429415 |
Recruitment Status :
Completed
First Posted : September 7, 2011
Last Update Posted : April 2, 2020
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Condition or disease | Intervention/treatment | Phase |
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Acute Asthma | Drug: Magnesium Sulfate Sandoz Drug: Sodium Chloride , USP PPC | Phase 2 |
The investigators plan the following specific aims:
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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.
- 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
- 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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 818 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Magnesium Nebulization Utilization in Management of Pediatric Asthma |
Actual Study Start Date : | September 26, 2011 |
Actual Primary Completion Date : | November 19, 2019 |
Actual Study Completion Date : | November 22, 2019 |
Arm | Intervention/treatment |
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Experimental: Experimental Group
Magnesium Sulfate Sandoz/PPC 600mg and Salbutamol (GlaxoSmithKline/Pharmascience) 5mg by inhalation via Aeroneb Go nebulizer (Philips) with Idehaler Pocket chamber DTF q 20 minutes, 3 treatments.
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Drug: Magnesium Sulfate Sandoz
Each treatment will utilize 600 mg (1.2 mL) of Magnesium Sulfate Sandoz
Other Name: Magnesium Sulfate, USP 50% PPC |
Placebo Comparator: Control Group
Sodium Chloride USP PPC/Omega (5.5%) placebo and salbutamol GlaxoSmithKline/Pharmascience 5 mg by inhalation via Aeroneb Go nebulizer Philips with Idehaler Pocket chamber DTF q 20 minutes, 3 treatments.
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Drug: Sodium Chloride , USP 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 Name: Sodium Chloride for Injection USP Omega Laboratories Ltd. |
- Hospitalization of Subject [ 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.
- Pediatric Respiratory Assessment Measure (PRAM) [ Time Frame: 0, 20, 40 60, 120, 180, 240 minutes post dose ]PRAM is a validated measure of asthma severity in the Emergency Department
- Changes in Vitals [ Time Frame: 0, 20, 40, 60, 120, 180, 240 minutes post dose ]Respiratory Rate, O2 saturation, Blood pressure
- Number of Salbutamol Treatments [ Time Frame: Up to 240 minutes post dose ]This measure of additional therapy may strengthen the measure of benefit of inhaled magnesium
- Medical History and Phenotype [ 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

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Ages Eligible for Study: | 2 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 2-17 years of age
- Diagnosis of asthma/reactive airways/viral wheeze, defined as this diagnosis made by a physician and at least one prior acute episode of wheezing with cough or dyspnea treated with inhaled ß2 agonists or oral corticosteroids. Our study population will exclude bronchiolitis and first-time wheeze (potential alternate diagnoses).
- Persistent moderate to severe airway obstruction after 3 doses of salbutamol and ipratropium (as per site specific standard of care guidelines) -, defined as a PRAM 5 or higher. A PRAM score of 5 or more following initial therapy indicates the child has at least moderate disease severity and has a high likelihood of being hospitalized.This group of children includes 84% of all pediatric asthma hospitalizations; therefore, finding an effective therapy for this population has great potential to significantly reduce hospitalizations. (Appendix B).
Exclusion Criteria:
- No previous history of wheezing or bronchodilator therapy. Some children who present with wheezing for the first time will have other diagnoses which would not be expected to respond to Mg.
- Patients who have already received IV Mg therapy during the index visit.
- Critically ill children requiring immediate intubation. These children need immediate ICU management and hospitalization.
- Children who in the opinion of the treating physician require a chest radiograph due to atypical clinical presentation and are found to have radiologist-confirmed pneumonia. These rare patients may have to be hospitalized primarily for treatment of the infection and may not respond to magnesium.
- Known co-existent renal, chronic pulmonary, neurologic, cardiac or systemic disease. These conditions may influence the response to Mg and hospitalization.
- Known hypersensitivity to Mg sulfate.
- Patients previously enrolled in the study.
- Insufficient command of the English and or French language.
- Lack of a home or cellular telephone.
- Known allergy/sensitivity to latex.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429415
Canada, Alberta | |
Alberta Children's Hospital | |
Calgary, Alberta, Canada, T3B 6A8 | |
Stollery Hospital | |
Edmonton, Alberta, Canada, T6G1C9 | |
Canada, British Columbia | |
BC Children's Hospital | |
Vancouver, British Columbia, Canada, V6H 3V4 | |
Canada, Manitoba | |
The Manitoba Institute of Child Health | |
Winnipeg, Manitoba, Canada, R3E3P4 | |
Canada, Ontario | |
Children's Hospital of Eastern Ontario | |
Ottawa, Ontario, Canada, K1H8L1 | |
The Hospital for Sick Children | |
Toronto, Ontario, Canada, M5V1X8 | |
Canada, Quebec | |
Ste Justine Hospital | |
Montreal, Quebec, Canada, H3T1C5 |
Principal Investigator: | Suzanne Schuh, MD | The Hospital for Sick Children |
Responsible Party: | Suzanne Schuh, Staff Physician, The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT01429415 |
Other Study ID Numbers: |
1000024908 |
First Posted: | September 7, 2011 Key Record Dates |
Last Update Posted: | April 2, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
pediatric Acute Asthma Inhaled Magnesium |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Magnesium Sulfate Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Anti-Arrhythmia Agents Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Tocolytic Agents Reproductive Control Agents |