Phase 4 N=50 Randomized Triple-blind Treatment

Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma Exacerbation

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT01515995 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcome: Primary: Change in Forced Expiratory Volume in One Second (FEV1) % — 3.6; 5 Percentage of FEV1

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Nebulized magnesium sulfate (Drug)
Age: Pediatric, Adult · 7+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Oct 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Forced Expiratory Volume in One Second (FEV1) %	3.6; 5	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01515995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.