Asthma study: Magnesium sulfate vs Normal Saline
Official title Magnesium Trial in Acute Asthma in Emergency Department
ClinicalTrials.gov ID: NCT06785272
What this study is testing
What is magnesium sulfate?
This is an investigational intravenous infusion being studied as a potential treatment for severe acute asthma. It is designed to relax the muscles in the airways to help them open up.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if giving magnesium through an IV early on reduces breathing difficulty in children with severe asthma.
- Who it's for
- The study is looking for children with severe asthma who still have trouble breathing after one hour of standard emergency care.
- What's involved
- Participants will receive either a magnesium IV or a placebo (a look-alike solution with no medicine) and have their breathing checked with a standard score.
- Time commitment
- The main check happens two hours after the IV starts, and the study tracks how well the child breathes during that time.
- Phase 3: a large, late-stage study
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- Age 2.00-17.99 years (prior to 18th birthday),
- Diagnosis of asthma, defined as an asthma or probable asthma diagnosis/asthma-like phenotype made by a physician (this includes ED physician) in a...
- Moderate-severe asthma after initial therapy with 3 treatments of inhaled salbutamol and ipratropium, defined as an eligibility PRAM ≥5, indicating a...
You likely can't join if
- Receipt of IVMg within 24 hours prior to ED arrival.
- Need for airway support on arrival. (Airway support on arrival meeting exclusion criteria will include immediate need for high flow nasal cannula...
- Known renal, chronic pulmonary, neurologic, cardiac or systemic disease: these may influence outcomes after Mg.
- Known hypersensitivity to Mg sulfate.
- Previous enrollment.
- Poor mastery of English and/or French language precluding informed consent understanding.
See the full eligibility criteria
- Age 2.00-17.99 years (prior to 18th birthday),
- Diagnosis of asthma, defined as an asthma or probable asthma diagnosis/asthma-like phenotype made by a physician (this includes ED physician) in a patient who in the opinion of the treating ED physician requires therapy...
- Moderate-severe asthma after initial therapy with 3 treatments of inhaled salbutamol and ipratropium, defined as an eligibility PRAM ≥5, indicating a strong association with hospitalization.
- Receipt of IVMg within 24 hours prior to ED arrival.
- Need for airway support on arrival. (Airway support on arrival meeting exclusion criteria will include immediate need for high flow nasal cannula therapy, non-invasive CPAP/bi-PAP ventilation or invasive ventilation...
- Known renal, chronic pulmonary, neurologic, cardiac or systemic disease: these may influence outcomes after Mg.
- Known hypersensitivity to Mg sulfate.
- Previous enrollment.
- Poor mastery of English and/or French language precluding informed consent understanding.
- No phone/email; unavailable for follow-up
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.