Nebulized Magnesium Sulfate in Pediatric Asthma

NCT00522444 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: 2008-0431
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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.

  through emergency admission, an average of less than 1 day

Study Arms (2)

nebulized magnesium sulfate

EXPERIMENTAL

6.3% solution of magnesium heptahydrate, which is equivalent to 3.18% anhydrous magnesium sulfate

Drug: Nebulized Magnesium Sulfate

normal saline nebulization

PLACEBO COMPARATOR

standard of care

Other: Nebulized normal saline

Interventions

Nebulized Magnesium Sulfate DRUG

6.3% solution of magnesium heptahydrate, which is equivalent to 3.18% anhydrous magnesium sulfate

Also known as: magnesium heptahydrate

nebulized magnesium sulfate

Nebulized normal saline OTHER

standard of care

normal saline nebulization

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Laurie Johnson, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2007
• First Posted: August 29, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 7, 2020

Record last verified: 2020-09