A Phase 3 interventional study of Nebulized Magnesium Sulfate and Nebulized normal saline in Asthma, sponsored by Children's Hospital Medical Center, Cincinnati. Withdrawn. Open to participants aged 7 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-09-07.
Sponsored by Children's Hospital Medical Center, Cincinnati · Phase 3, Interventional, and Treatment
Nebulized Magnesium Sulfate has been shown to be of benefit in adults with acute asthma exacerbations, though limited work has been done in the pediatric population. Current therapeutic questions include the effect of more than one dose of nebulized magnesium, the possibility of a sustained effect (greater than 20 minutes) after a treatment, the potential benefit in children younger than 5 years of age, and the use of an asthma score to re-assess patients after treatment with this medication. The purpose of this double-blind randomized placebo-controlled clinical trial is the evaluate the effect of multiple doses of nebulized magnesium sulfate versus saline in addition to standard asthma therapy on clinical asthma score and FEV1 in children 7 to 18 years of age with a moderate to severe acute asthma exacerbation. Our hypothesis is that nebulized magnesium sulfate, when added to traditional bronchodilator therapy, will improve acute asthma exacerbations more rapidly than standard therapy alone. The primary outcomes are asthma score and FEV1 values obtained after two nebulized magnesium sulfate compared to placebo treatments. This therapy will be supplemental to standard therapy of albuterol and ipratropium nebulized treatments and systemic corticosteroids. The secondary outcome is patient disposition (discharge home or hospitalization). Patients with known asthma will be approached for enrollment and informed consent obtained if the asthma score after the first albuterol treatment is "2" or greater. One hundred-seventy patients will be enrolled and randomized to either the treatment group or the placebo group. The change from baseline in asthma scores and FEV1 values will be compared among the control and treatment groups to assess for any benefit of the addition of nebulized magnesium sulfate to the treatment regimen.
Acute asthma exacerbations continue to be a growing heath care dilemma, even as increased efforts are made in preventing such exacerbations. The standard of care for such exacerbations typically involves inhaled beta-agonist therapy and oral steroids. Patients who are refractory to these treatments may require intravenous access for the purposes of delivering additional medications, including magnesium sulfate. Intravenous magnesium sulfate has been shown to be beneficial in moderate and severe acute asthma exacerbations in adults and children, and new research indicates a trend toward benefits from nebulized magnesium sulfate, even in those with a mild exacerbation of asthma. Delivery of magnesium sulfate via the inhalation route is less invasive than the intravenous route, which is preferable in the pediatric population. The possible short-term benefits of the nebulized form of magnesium sulfate include decreased ED length of stay and prevention of admission to the intensive care unit if the patient must be hospitalized for further treatments. The specific aim of this study is to evaluate the effect of the addition of nebulized magnesium sulfate to our standard emergency department therapy by comparing the change from baseline of asthma scores and FEV1 (forced expiratory volume in 1 second) in children with acute asthma exacerbations.
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Exclusion Criteria:
6.3% solution of magnesium heptahydrate, which is equivalent to 3.18% anhydrous magnesium sulfate
Drug: Nebulized Magnesium Sulfate
standard of care
Other: Nebulized normal saline
6.3% solution of magnesium heptahydrate, which is equivalent to 3.18% anhydrous magnesium sulfate
Also known as: magnesium heptahydrate
standard of care
Change is PASS Asthma Score
The primary outcome event for the assessment of efficacy in all patients is the change in PASS asthma score from Time Zero to Times One and Two.
Time frame: through emergency admission, an average of less than 1 day
No study locations are listed for this record.
This study is withdrawn, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati