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Electrolyte Supplement

Magnesium for Asthma (MAGICIAN Trial)

Hamilton, Canada

Phase 3

Waitlist Available

Led By Suzanne Schuh, MD

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 2-17 years

Diagnosis of asthma made by a physician and at least one prior episode of asthma-like symptoms responsive to inhaled ß2 agonists or oral/inhaled CSs

Must not have

Receipt of IVMg within 24 hours prior to ED arrival

Known renal, chronic pulmonary, neurologic, cardiac or systemic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (pre-intervention) to 10,20,30,60,120, and 180 minutes post intervention (blood pressure).

Awards & highlights

Pivotal Trial

Summary

This trial seeks to determine if giving intravenous magnesium (IVMg) early to children with severe asthma can help improve their breathing difficulties. The study will use a specific measure called the Pediatric Respiratory

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Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While the document doesn't list specific side effects, it mentions that IVMg can cause low blood pressure and requires close monitoring during administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 2 and 17 years old.

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

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My asthma is severe despite using salbutamol and ipratropium.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a known chronic disease affecting my kidneys, lungs, nervous system, heart, or other systemic conditions.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (pre-intervention) to 10,20,30,60,120, and 180 minutes post intervention (blood pressure).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (pre-intervention) to 10,20,30,60,120, and 180 minutes post intervention (blood pressure).

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (pre-intervention) to 10,20,30,60,120, and 180 minutes post intervention (blood pressure). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pediatric Respiratory Assessment Measure (PRAM) score

Secondary study objectives

Changes in blood pressure

Changes in oxygen saturation

Changes in respiratory rate

+5 more

Side effects data

From 2012 Phase 3 trial • 104 Patients • NCT00316914

74%

Diarrhea

64%

Nausea

50%

Constipation

38%

Vomiting

20%

Peripheral sensory neuropathy

18%

Neutrophil count decreased

18%

Serum magnesium increased

14%

Fatigue

Hypersensitivity

Peripheral motor neuropathy

Hand-and-foot syndrome

Thrombosis

Leukocyte count decreased

Anorexia

Hemoglobin decreased

Platelet count decreased

Serum sodium decreased

Myalgia

Erythema multiforme

Rash desquamating

Serum potassium decreased

Cholecystitis

Abdominal infection

Vascular access complication

Alanine aminotransferase increased

Myocardial ischemia

Ear, nose and throat examination abnormal

Mucositis oral

Alkaline phosphatase increased

Weight loss

Serum magnesium decreased

Muscle weakness

Headache

Rash acneiform

Hypotension

Aspartate aminotransferase increased

Blood glucose increased

Dehydration

Dysgeusia

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Ca/Mg

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental GroupExperimental Treatment1 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 GroupPlacebo Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

magnesium sulfate

2019

Completed Phase 3

~600

0 / 5Eligibility criteria met