NCT01429415: MAGNUMPA

Magnesium Nebulization Utilization in Management of Pediatric Asthma

Completed Phase 2 Last updated 2 April 2020

What this trial tests

Phase 2 trial testing Magnesium Sulfate Sandoz in Acute Asthma in 818 participants. Completed in 22 November 2019.

Timeline

26 September 2011

Primary endpoint
19 November 2019

22 November 2019

Quick facts

Lead sponsor	The Hospital for Sick Children
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	818
Start date	26 September 2011
Primary completion	19 November 2019
Estimated completion	22 November 2019
Sites	7 locations across Canada

Drugs / interventions tested

• Magnesium Sulfate Sandoz — full drug profile →
• Sodium Chloride , USP PPC — full drug profile →

Conditions studied

• Acute Asthma — all drugs for Acute Asthma →

Sponsor

The Hospital for Sick Children

Who can join

Adults 2 to 17, any sex, with Acute Asthma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. ESC Working Group on Cellular Biology of the Heart: position paper for Cardiovascular Research: tissue engineering strategies combined with cell therapies for cardiac repair in ischaemic heart disease and heart failure.
   Madonna R, Van Laake LW, Botker HE, Davidson SM, et al · · 2019 · cited 82× · PMID 30657875 · DOI 10.1093/cvr/cvz010
2. 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.
   Schuh S, Sweeney J, Rumantir M, Coates AL, et al · · 2020 · cited 29× · PMID 33231663 · DOI 10.1001/jama.2020.19839
3. 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.
   Schuh S, Freedman SB, Zemek R, Plint AC, et al · · 2021 · cited 12× · PMID 34279646 · DOI 10.1001/jamanetworkopen.2021.17542