Magnesium for Asthma

(MAGICIAN Trial)

Recruiting at 5 trial locations

Overseen By Yaron Finkelstein, MD

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Suzanne Schuh

Disqualifiers: Renal, Pulmonary, Neurologic, Cardiac, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 3 hours

192 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if early intravenous magnesium sulfate can help children in the emergency room who still experience severe asthma symptoms after initial treatment. Researchers seek to discover whether magnesium can significantly alleviate breathing distress compared to a placebo (a harmless, inactive substance). Children who may qualify are those with asthma who continue to have moderate to severe symptoms after initial treatment with inhaled medications in the emergency department. The results could establish magnesium as a standard treatment or suggest it should not be used, potentially saving costs. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in asthma treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have received intravenous magnesium within 24 hours before arriving at the emergency department.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that administering magnesium sulfate through an IV can be a safe option for children experiencing asthma attacks. Studies have found that it reduces the need for hospital stays and improves breathing in children, with rare side effects. In adults, this treatment also lowers the risk of hospitalization, with only a small chance of side effects. Overall, magnesium sulfate administered in this manner appears well-tolerated and could aid in treating severe asthma attacks in children. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for asthma?

Magnesium sulfate is unique because it offers a different approach for treating asthma by targeting smooth muscle relaxation in the airways, potentially reducing constriction. Unlike standard treatments like inhaled corticosteroids or bronchodilators, which primarily focus on reducing inflammation or opening the airways, magnesium sulfate works by relaxing the muscles around the airways. Researchers are excited about this treatment because it may provide rapid relief during asthma attacks and could be particularly beneficial for patients who don't respond well to conventional therapies. Plus, its intravenous administration ensures quick action, which is crucial during emergency situations.

What evidence suggests that magnesium sulfate might be an effective treatment for asthma?

Research has shown that administering magnesium through an IV can reduce hospital visits for children experiencing sudden asthma attacks. In this trial, participants in the experimental group will receive a single dose of intravenous magnesium sulfate. One study found that early administration in the emergency room improved breathing and might reduce the likelihood of hospitalization. Additionally, a review found that some studies support magnesium's positive effects on breathing, suggesting it might help during asthma attacks. However, results are mixed, and not all studies agree. Researchers continue to study this treatment to fully understand its benefits and optimal use. ^{6 7 8 9 10}

Who Is on the Research Team?

Suzanne Schuh, MD

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

This trial is for children with severe acute asthma who still have moderate to severe respiratory distress after one hour of initial emergency department therapy. It's not clear if they should be given magnesium sulfate (IVMg) or a placebo, as past studies are inconclusive about its benefits.

Inclusion Criteria

I am between 2 and 17 years old.

I have asthma diagnosed by a doctor and have responded to asthma treatments before.

My asthma is severe despite using salbutamol and ipratropium.

Exclusion Criteria

Need for airway support on arrival

I received IV magnesium within 24 hours before coming to the emergency department.

Known hypersensitivity to Mg sulfate

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Initial Emergency Department Therapy

Participants receive initial therapy with systemic corticosteroids and inhaled salbutamol and ipratropium

1 hour

1 visit (in-person)

Treatment

Participants receive a 30-minute IV infusion of magnesium sulfate or placebo, followed by monitoring for 3 hours

3 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including unscheduled asthma-related visits

72 hours

What Are the Treatments Tested in This Trial?

Interventions

• Magnesium Sulfate

Trial Overview

The study tests whether early IVMg treatment improves breathing difficulties in these children compared to a placebo. The main measure is the change in their Pediatric Respiratory Assessment Measure (PRAM) score at three hours after starting treatment.

How Is the Trial Designed?

Group I: Experimental Group Experimental Treatment 1 Intervention

This group will receive a single dose of intravenous magnesium sulfate over 30 minutes. After this treatment has been completed, they may also get further Ventolin inhalations or other asthma medicines which are not part of the study, as recommended by the emergency physician. The participant will be monitored closely by the study nurse who will measure their breathing, heart rate, blood pressure and oxygen for 3 hours after the study treatment. The study nurse will also notify the emergency physician of any major changes.

Group II: Placebo Group Placebo Group 1 Intervention

This group, will receive a single dose of intravenous placebo (normal saline, i.e. salt water) over 30 minutes. After this treatment has been completed, they may also get further Ventolin inhalations or other asthma medicines which are not part of the study, as recommended by the emergency physician who is taking care of the participant. They will be monitored closely by the study nurse who will measure the participant's breathing, heart rate, blood pressure and oxygen for 3 hours after the study treatment. The study nurse will also notify the emergency physician of any major changes in their health.

Who Is Running the Clinical Trial?

Suzanne Schuh

Lead Sponsor

McMaster Children's Hospital

Collaborator

Trials

43

Recruited

19,900+

St. Justine's Hospital

Collaborator

Trials

205

Recruited

87,300+

Children's Hospital of Eastern Ontario

Collaborator

Trials

134

Recruited

61,000+

The Hospital for Sick Children

Collaborator

Trials

724

Recruited

6,969,000+

Alberta Children's Hospital

Collaborator

Trials

58

Recruited

44,700+

Stollery Children's Hospital

Collaborator

Trials

25

Recruited

25,900+

Published Research Related to This Trial

In a study of 54 children with moderate to severe asthma exacerbations, the administration of high-dose magnesium sulfate did not significantly improve asthma symptoms compared to a placebo, as measured by Pulmonary Index scores.

There was no notable difference in hospitalization rates or time to meet discharge criteria between the magnesium and placebo groups, indicating that magnesium sulfate may not be an effective routine treatment for acute asthma in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of magnesium in the emergency department treatment of children with asthma. Scarfone, RJ., Loiselle, JM., Joffe, MD., et al.[2006]

A review of 16 studies indicates that intravenous bolus magnesium sulphate is safe for treating children with acute severe asthma in non-critical care settings.

Safety measures, such as line of sight nursing and cardiorespiratory monitoring, are essential when administering magnesium sulphate to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is intravenous magnesium sulphate safe to be administered outside the critical care setting? de Havilland, A., Hariharan, G., Puvvadi, R.[2022]

Magnesium sulfate can be beneficial for asthmatic patients who do not respond well to initial treatments like beta-agonists and corticosteroids, potentially acting as a calcium antagonist and aiding in ion flux across cell membranes.

While routine use of magnesium sulfate in emergency departments for acute asthma is not recommended, it may provide some benefits as an adjunct therapy for severely ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of the intravenous and nebulized magnesium sulfate for the treatment of the acute asthma in the emergence]. Barbosa, FT., Barbosa, LT., Cunha, RM., et al.[2014]

A review of 8 studies involving 447 children found that prolonged magnesium sulfate infusions (over 1 hour) are used for treating refractory asthma, but most studies did not assess clinical outcomes like lung function or hospital admissions.

While magnesium sulfate infusions were generally safe, with only 1.1% of patients experiencing high magnesium levels, adverse events such as hypotension and nausea were more common in those receiving infusions lasting over 24 hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Magnesium Sulfate Infusions for Status Asthmaticus in Children: A Systematic Review. Johnson, PN., Drury, AS., Gupta, N.[2022]

Citations

1.

aafp.org

aafp.org/pubs/afp/issues/2021/0215/p245.html

Magnesium Sulfate for Acute Asthma in Children & Adults

22% lower admission rate in children, 7% lower admission rate in adults, 8% lower admission rate in adults with life-threatening asthma exacerbations.

2.

publications.aap.org

publications.aap.org/hospitalpediatrics/article/11/8/785/179880/Intravenous-Magnesium-and-Hospital-Outcomes-in

Intravenous Magnesium & Hospital Outcomes in Asthma

Pediatric studies demonstrate that IVMg improves pulmonary function and may reduce hospital admission when administered early in the emergency ...

3.

frontiersin.org

frontiersin.org/journals/allergy/articles/10.3389/falgy.2023.1211949/full

Magnesium Sulfate for Severe Asthma: A Review

Conclusion: Up to two out of three studies revealed an effect of MgSO4 treatment for asthma exacerbation when assessed by FEV1/PEF, but fewer ...

4.

shmpublications.onlinelibrary.wiley.com

shmpublications.onlinelibrary.wiley.com/doi/10.12788/jhm.3405

Trends in Intravenous Magnesium Use and Outcomes for ...

IV magnesium use for asthma hospitalization more than doubled over 8 years (17% vs. 36%; P < .001). Yearly trends were not significantly ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/26649938/

High-Dose Magnesium Sulfate for Severe Asthma in ED

Objective: To assess the efficacy of a high-dose prolonged magnesium sulfate infusion in patients with severe, noninfectious-mediated asthma.

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1526054224000137

Intravenous magnesium sulfate for asthma exacerbations ...

The use of IV-MgSO4 demonstrated a reduction in the hospitalization rate and PEFR improvement in children with asthma exacerbations. Adverse effects were rare.

7.

frontiersin.org

frontiersin.org/journals/pediatrics/articles/10.3389/fped.2022.860921/full

Efficacy and Safety of Prolonged Magnesium Sulfate ...

Our study noted that the use of magnesium sulfate infusions was not associated with lower odds of MV requirement or PICU LOS when controlling ...

8.

thennt.com

thennt.com/nnt/intravenous-magnesium-sulfate-acute-asthma-exacerbation-adults/

Intravenous Magnesium Sulfate for Acute Asthma ...

Intravenous magnesium sulfate for acute asthma exacerbation in adults reduces risk of hospitalization; likely causes minimal increase in adverse events.

9.

accp1.onlinelibrary.wiley.com

accp1.onlinelibrary.wiley.com/doi/10.1002/jcph.6179

Pharmacokinetics and Pharmacodynamics of Intravenous ...

The findings signal that IVMg may be an efficacious and safe option for treating moderate–severe pediatric acute asthma exacerbations in the ED.

10.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11584261/

Safety and Effectiveness of Prolonged Magnesium Sulfate ...

Prolonged MgSO 4 infusion is safe at a maximum dose of 30 mg/kg/h and may be beneficial for children with asthma exacerbation.