Two Doses of the Intravenous Magnesium Sulfate Versus the Standard Single Dose ,With/ Without the Nebulized Budesonide For the Management of the Severe Asthma Exacerbation in the Emergency Room; A Randomized Controlled Trial.

NCT ID: NCT02455687

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2025-01-31

Brief Summary

Many studies have investigated the efficacy and safety of Intravenous magnesium sulfate and inhaled steroids in addition to the standard treatment for patients with severe asthma attacks.

In this 2x2 factorial design blinded randomized study, no interaction of hypothesized treatments is expected.Investigators hypothesize that two doses of intravenous magnesium sulfate,a high dose followed by a (lower) standard dose, will shorten the time to medical readiness for discharge compared to a single standard dose followed by placebo.The second hypothesis is that nebulized inhaled budesonide will be superior to placebo.

Detailed Description

Patient with a severe asthma attack will be admitted to the observation area in the Pediatric Emergency Center and assessed for eligibility for the study by the attending physician, based upon our study inclusion/exclusion criteria.

Eligible patients will be enrolled after obtaining written consent from the parents. Patients will receive routine treatment for a severe asthma attack, such as inhaled bronchodilators, plus intravenous steroids and supplementary oxygen if needed. Standard blood work and chest X-Ray will be obtained and bronchial asthma severity score will be measured at baseline before starting treatment,and then at 4,8,12,24,36,48 hr and thereafter. The medical team as well as parents and patient will be blinded to the medications delivered. The patient will be randomized into one of the four study groups and adverse effects of the medications in each group will be monitored and documented carefully.

Conditions

Bronchial Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Hi-Mg + Bud

Group one will receive a high,then standard dose of intravenous magnesium sulfate with blinded nebulized budesonide.

Group Type: ACTIVE_COMPARATOR

Hi-dose iv MgSO4

Intervention Type: DRUG

Nebulized budesonide

Intervention Type: DRUG

Hi-Mg + P

Group two will receive a high,then standard dose of intravenous magnesium sulfate with blinded nebulized normal saline.

Group Type: PLACEBO_COMPARATOR

Hi-dose iv MgSO4

Intervention Type: DRUG

Nebulized normal saline

Intervention Type: DRUG

Std-Mg + Bud

Group three will receive a single standard dose of intravenous magnesium sulfate plus one dose of intravenous normal saline with blinded nebulized budesonide.

Group Type: ACTIVE_COMPARATOR

Nebulized budesonide

Intervention Type: DRUG

Std-dose iv MgSO4

Intervention Type: DRUG

St-Mg + P

Group four will receive a single dose of intravenous magnesium sulfate plus one dose of intravenous normal saline with blinded nebulized normal saline

Group Type: PLACEBO_COMPARATOR

Std-dose iv MgSO4

Intervention Type: DRUG

Nebulized normal saline

Intervention Type: DRUG

Interventions

Hi-dose iv MgSO4

Intervention Type: DRUG

Nebulized budesonide

Intervention Type: DRUG

Std-dose iv MgSO4

Intervention Type: DRUG

Nebulized normal saline

Intervention Type: DRUG

Other Intervention Names

Pulmicort

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamad Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Khalid Alansari, MD

Role: STUDY_DIRECTOR

Sidra Medicine

Locations

Hamad Medical Corporation

Doha, , Qatar

Site Status: RECRUITING

Countries

Qatar

Central Contacts

Khalid Alansari, MD

Role: CONTACT

kalansari@hamad.qa

+974-55336166

Faten Abumusa, MD

Role: CONTACT

fmoussa@hamad.qa

+974-55312922

Other Identifiers

1400046

Identifier Type: -

Identifier Source: org_study_id