Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma Exacerbation

January 29, 2019 updated by: University of Texas Southwestern Medical Center

Nebulized Magnesium Sulfate Versus Normal Saline as a Vehicle for Albuterol in Children With Moderate to Severe Asthma Exacerbation: a Randomized Controlled Trial

The purpose of this study is to evaluate the effectiveness of nebulized magnesium sulfate as a vehicle for albuterol in children with moderate to severe asthma exacerbation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients presenting to the Emergency Department for acute asthma exacerbation will receive standard care of up to three doses of albuterol and ipratropium bromide plus oral steroid medication. Those seven years of age and older who require further treatment will be screened for eligibility. Eligibility screening will comprise measurement of forced expiratory volume in one second (FEV1) with a bedside spirometer by a respiratory therapist. Children under the age of seven are generally unable to complete spirometry maneuvers and will thus be excluded. The Pediatric Asthma Severity Score (PASS) will also be noted by a respiratory therapist. Patients able to complete spirometry testing and with an FEV1 less than 70% of predicted (the definition of moderate asthma exacerbation) will be enrolled. Enrolled patients will be randomized to receive either Children's Medical Center standard care of 15 mg albuterol diluted in 22 ml of normal saline or the study intervention of 15 mg of albuterol diluted in 22 ml of magnesium sulfate solution. This solution will be prepared at the time of use by a pharmacist in the Emergency Department and will consist of 22 ml of a commercially available 40 mg/ml magnesium sulfate solution (880 mg). The nebulizer treatment will be given over approximately one hour via a large volume nebulizer at 25 ml/hr. Physicians, nurses, and respiratory therapists will be blinded to the diluent used. Vital signs will be noted at baseline. Heart rate, heart rhythm, respiratory rate, and pulse oximetry will be monitored continuously while blood pressure will be measured at baseline and every 15 minutes during study medication administration. The study physician, treating physician, and/or bedside nurse will monitor these values for any clinically significant changes. At the end of the 15 mg albuterol treatment FEV1 and PASS will again be noted. Any further treatments needed, as determined by the treating physician, will be given following Children's Medical Center standard of care. At the discretion of the treating physician intravenous magnesium sulfate may be used post study intervention. The dose used for study participants will be the Children's Medical Center standard dose of 75 mg/kg (max 3 g) minus 880 mg to avoid the risk of magnesium sulfate overdose. Further treatments and patient disposition will be observed by study personnel and noted. Bounce-back rates will be collected by review of enrolled patients' medical record.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • Children's Medical Center Dallas

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients age ≥ seven years
  • Previous diagnosis of asthma or previous episode of wheezing treated with beta-agonist medication
  • Able to complete bedside spirometry
  • FEV1 < 70% predicted

Exclusion Criteria:

  • Known allergy to magnesium sulfate
  • Known contra-indication to albuterol
  • Respiratory distress occurring as a result of bedside spirometry
  • History of neuromuscular disease, cardiac disease, renal disease, or underlying chronic lung disease
  • Pregnancy
  • Use of oral steroid medication within 72 hours of presentation
  • Radiographic evidence of pneumonia at presentation
  • Intubation during the current encounter prior to study enrollment
  • Administration of intravenous magnesium sulfate prior to study enrollment
  • Prior participation in this study

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Magnesium sulfate group
15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour
Drug: Nebulized magnesium sulfate

15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour

Versus

15 mg albuterol in 22 ml of normal saline via nebulizer over one hour

Other Names:
  • Inhaled magnesium sulfate
Active Comparator: Normal Saline group
15 mg albuterol in 22 ml of normal saline solution via nebulizer over one hour
Drug: Nebulized magnesium sulfate

15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour

Versus

15 mg albuterol in 22 ml of normal saline via nebulizer over one hour

Other Names:
  • Inhaled magnesium sulfate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Forced Expiratory Volume in One Second (FEV1) %
Time Frame: Baseline and one hour after treatment
Change in forced expiratory volume in one second (FEV1) as measured by bedside spirometry before and after study intervention.
Baseline and one hour after treatment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas Southwestern Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mohamed Badawy, MD, UT Southwestern Medical Center

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ( STU 072011-043)

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.

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