Nebulized Magnesium Sulfate in Pediatric Asthma

September 4, 2020 updated by: Children's Hospital Medical Center, Cincinnati

Nebulized Magnesium Sulfate Compared to Saline in Addition to Albuterol and Ipratropium Treatments in Moderate to Severe Pediatric Asthmatic Patients: A Randomized Controlled Clinical Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pediatric Patients ages 7-18 years old
  • Parental report of previous history of asthma or wheezing episode documented by physician at least 3 months prior to enrollment
  • Acute Asthma exacerbation as defined by attending physician and asthma score (PASS) of greater than or equal to 2 after initial albuterol treatment

Exclusion Criteria:

  • Temperature in triage of greater than or equal to 39 degrees Celsius
  • Systemic corticosteroids in past 72 hours
  • Medical history significant for cardiac, renal, or malignant disease, or bronchopulmonary dysplasia or cystic fibrosis
  • Patients whose care is initiated in the trauma bay due to need for rapid stabilization or any patient deemed too ill to participate by the attending ED physician
  • Altered Mental Status (Glasgow Coma Score of < 15)
  • Asthma Score (PASS) of > 6, and in conjunction with FEV1 < 45% predicted
  • Oxygen saturation < 90% while on 6L of 100% oxygen via face mask
  • Respiratory distress occurring after FEV1 attempt in conjunction with any increase in asthma score (PASS) from previous score
  • Enrollment in any other research study in the previous 30 days
  • Previous enrollment in this RCT
  • Initial administration of continuously nebulized albuterol or dose of IV Magnesium Sulfate in the ED

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: nebulized magnesium sulfate
6.3% solution of magnesium heptahydrate, which is equivalent to 3.18% anhydrous magnesium sulfate
Drug: Nebulized Magnesium Sulfate
6.3% solution of magnesium heptahydrate, which is equivalent to 3.18% anhydrous magnesium sulfate
Other Names:
  • magnesium heptahydrate
PLACEBO_COMPARATOR: normal saline nebulization
standard of care
Other: Nebulized normal saline
standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change is PASS Asthma Score
Time Frame: through emergency admission, an average of less than 1 day
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.
through emergency admission, an average of less than 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Laurie Johnson, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2007

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

August 28, 2007

First Submitted That Met QC Criteria

August 28, 2007

First Posted (ESTIMATE)

August 29, 2007

Study Record Updates

Last Update Posted (ACTUAL)

September 7, 2020

Last Update Submitted That Met QC Criteria

September 4, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-0431

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe