Comparing two doses of intravenous magnesium sulfate and nebulized budesonide for severe asthma attacks

Two Doses of the Intravenous Magnesium Sulfate Versus the Standard Single Dose With/Without Nebulized Budesonide for the Emergency Management of the Severe Asthma. A Randomized Controlled Trial.

This study is testing if giving kids with severe asthma attacks a higher dose of magnesium sulfate along with a breathing treatment can help them feel better and go home sooner.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 2 Years to 14 Years
• Sex: All
• Sponsor: Hamad Medical Corporation (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 1 site (Doha)
• Trial ID: NCT02455687 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of two doses of intravenous magnesium sulfate compared to a single standard dose in managing severe asthma exacerbations in children aged 2-14. The study employs a 2x2 factorial design, where participants will also receive either nebulized budesonide or a placebo. Patients will be monitored for their asthma severity and readiness for discharge after treatment. The trial aims to determine if the combination of high-dose magnesium sulfate and nebulized budesonide can improve outcomes for children experiencing severe asthma attacks.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 2-14 years with a known diagnosis of bronchial asthma presenting with a severe asthma exacerbation.

Not a fit: Patients who are critically ill, require immediate intubation, or have significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols for children suffering from severe asthma exacerbations, potentially reducing hospital stay duration.

How similar studies have performed: Previous studies have shown promising results with intravenous magnesium sulfate and nebulized steroids in treating severe asthma, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. Children 2-14 years of age.
2. Known to have bronchial asthma.
3. Presenting in severe asthma exacerbation
4. Asthma severity score 8 or higher according to PRAM asthma severity .

Exclusion Criteria:

1. Prematurity \<34 weeks of gestation.
2. Critically ill children requiring immediate intubation or ICU admission.
3. Transfers from other institutions.
4. Adverse drug reaction or allergy to budesonide,salbutamol,ipratropium bromide, prednisone, prednisolone, methylprednisolone, or magnesium sulfate.
5. History of neuromuscular disease, cardiac disease, renal disease, liver disease.
6. Underlying chronic lung disease.
7. Radiographic evidence of pneumonia or lung collapse .
8. Hemodynamic instability.
9. Instrumented airway or Tracheotomy.
10. Colostomy or ileostomy.
11. Malabsorption disorder.
12. Known vitamin D deficiency.
13. Receiving Milk of Magnesium for Constipation
14. Chronic diarrhea (duration for 2 weeks)
15. Diuretics use.
16. Immunodeficiency.

Where this trial is running

Doha

• Hamad Medical Corporation — Doha, Qatar (Recruiting)

Study contacts

• Study coordinator: Khalid Alansari, MD

Conditions Bronchial Asthma; Intravenous magnesium sulfate; Inhaled budesonide