- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01429415
Magnesium Nebulization Utilization in Management of Pediatric Asthma (MAGNUMPA)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators plan the following specific aims:
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T3B 6A8
- Alberta Children's Hospital
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Edmonton, Alberta, Canada, T6G1C9
- Stollery Hospital
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- BC Children's Hospital
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Manitoba
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Winnipeg, Manitoba, Canada, R3E3P4
- The Manitoba Institute of Child Health
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Ontario
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Ottawa, Ontario, Canada, K1H8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, Canada, M5V1X8
- The Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canada, H3T1C5
- Ste Justine Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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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Each treatment will utilize 600 mg (1.2 mL) of Magnesium Sulfate Sandoz
Other Names:
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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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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospitalization of Subject
Time Frame: Up to 24 hours after treatment
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Defined as admission to an inpatient unit within 24hours of the start of experimental therapy due to continued/worsening distress.
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Up to 24 hours after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pediatric Respiratory Assessment Measure (PRAM)
Time Frame: 0, 20, 40 60, 120, 180, 240 minutes post dose
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PRAM is a validated measure of asthma severity in the Emergency Department
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0, 20, 40 60, 120, 180, 240 minutes post dose
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Changes in Vitals
Time Frame: 0, 20, 40, 60, 120, 180, 240 minutes post dose
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Respiratory Rate, O2 saturation, Blood pressure
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0, 20, 40, 60, 120, 180, 240 minutes post dose
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Number of Salbutamol Treatments
Time Frame: Up to 240 minutes post dose
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This measure of additional therapy may strengthen the measure of benefit of inhaled magnesium
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Up to 240 minutes post dose
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Medical History and Phenotype
Time Frame: Baseline
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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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Baseline
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Collaborators and Investigators
Publications and helpful links
General Publications
- Schuh S, Freedman SB, Zemek R, Plint AC, Johnson DW, Ducharme F, Gravel J, Thompson G, Curtis S, Stephens D, Coates AL, Black KJ, Beer D, Sweeney J, Rumantir M, Finkelstein Y; Pediatric Emergency Research Canada. Association Between Intravenous Magnesium Therapy in the Emergency Department and Subsequent Hospitalization Among Pediatric Patients With Refractory Acute Asthma: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2117542. doi: 10.1001/jamanetworkopen.2021.17542.
- Schuh S, Sweeney J, Rumantir M, Coates AL, Willan AR, Stephens D, Atenafu EG, Finkelstein Y, Thompson G, Zemek R, Plint AC, Gravel J, Ducharme FM, Johnson DW, Black K, Curtis S, Beer D, Klassen TP, Nicksy D, Freedman SB; Pediatric Emergency Research Canada (PERC) Network. Effect of Nebulized Magnesium vs Placebo Added to Albuterol on Hospitalization Among Children With Refractory Acute Asthma Treated in the Emergency Department: A Randomized Clinical Trial. JAMA. 2020 Nov 24;324(20):2038-2047. doi: 10.1001/jama.2020.19839.
- Schuh S, Sweeney J, Freedman SB, Coates AL, Johnson DW, Thompson G, Gravel J, Ducharme FM, Zemek R, Plint AC, Beer D, Klassen T, Curtis S, Black K, Nicksy D, Willan AR; Pediatric Emergency Research Canada Group. Magnesium nebulization utilization in management of pediatric asthma (MagNUM PA) trial: study protocol for a randomized controlled trial. Trials. 2016 May 24;17(1):261. doi: 10.1186/s13063-015-1151-x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Magnesium Sulfate
Other Study ID Numbers
- 1000024908
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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