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Nebulized Magnesium Sulfate in Pediatric Asthma

This study has been terminated.
(institution in Canada is conducting a similar clinical trial with potential of validating use.)
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00522444
First received: August 28, 2007
Last updated: February 5, 2014
Last verified: August 2007
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Nebulized Magnesium Sulfate
Phase 3

Children's Hospital Medical Center, Cincinnati has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Enrollment: 34
Study Start Date: September 2007
  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522444

Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Laurie Johnson, MD Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00522444     History of Changes
Other Study ID Numbers: 06-10-38, IND#74,074
Study First Received: August 28, 2007
Last Updated: February 5, 2014
Health Authority: United States: Food and Drug Administration
United States: Cincinnati Children's Hopsital Medical Center Institutional Review Board

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Magnesium Sulfate
Analgesics
Anesthetics
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on November 27, 2014