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AsthmaPhase 4NCT01515995

Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma Exacerbation

A Phase 4 study testing Nebulized magnesium sulfate in people with Asthma, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 7 to 18 years
Conditions the study is for
Asthma
What is being tested?
Nebulized magnesium sulfate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
Jan 2012to Oct 2015
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Medical Center Dallas

    Dallas, Texas, 75390

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Asthma
Being tested
Nebulized magnesium sulfate
Keywords
Magnesium sulfate, Childhood asthma, Emergency department
Medical subject headings
Asthma, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nebulized magnesium sulfateDrug

    Also called Inhaled 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

Study groups in NCT01515995
Study groupRoleWhat they receive
Magnesium sulfate groupExperimental15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour
Receives: Drug: Nebulized magnesium sulfate
Normal Saline groupActive comparator15 mg albuterol in 22 ml of normal saline solution via nebulizer over one hour
Receives: Drug: Nebulized magnesium sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Forced Expiratory Volume in One Second (FEV1) %

    Change in forced expiratory volume in one second (FEV1) as measured by bedside spirometry before and after study intervention.

    Measured: Baseline and one hour after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01515995
Sponsor's protocol ID
( STU 072011-043)
Status last verified
Jan 2019
First submitted
11 Jan 2012
Last updated
21 Feb 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nebulized magnesium sulfate in people with Asthma, run by University of Texas Southwestern Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Forced Expiratory Volume in One Second (FEV1) % (time frame: Baseline and one hour after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.

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