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.

NCT02455687 | Unknown Phase 3 DMC

• 1 other identifier: 1400046
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchial Asthma

Keywords

Bronchial Asthma; Intravenous magnesium sulfate; Inhaled budesonide

Outcome Measures

Primary Outcomes (1)

• Time to medical readiness for discharge.

  The aim of the study is to find out if the two doses of intravenous magnesium sulfate 100 mg/kg followed by 50 mg/kg with or without nebulized budesonide would shorten the length of the emergency center's stay in comparison to the 50 mg/kg dose with or without nebulized budesonide in treating severe asthma attack in children, who are admitted to the pediatric emergency center Al-Sadd, in a double blinded randomized controlled trial. .

  3 years

Secondary Outcomes (4)

• Overall length of the hospital stay (hours/days) .

  3 years

• The rate of admission to pediatric intensive care unit (%)

  3 years

• Comparison of clinical response in severity score (%)

  3 years

• Frequency of need for revisit and readmission to pediatric emergency center for same diagnosis(%)

  3 years

Study Arms (4)

Hi-Mg + Bud

ACTIVE COMPARATOR

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

Drug: Hi-dose iv MgSO4; Drug: Nebulized budesonide

Hi-Mg + P

PLACEBO COMPARATOR

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

Drug: Hi-dose iv MgSO4; Drug: Nebulized normal saline

Std-Mg + Bud

ACTIVE COMPARATOR

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

Drug: Nebulized budesonide; Drug: Std-dose iv MgSO4

St-Mg + P

PLACEBO COMPARATOR

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

Drug: Std-dose iv MgSO4; Drug: Nebulized normal saline

Interventions

Hi-dose iv MgSO4 DRUG

Hi-Mg + Bud; Hi-Mg + P

Nebulized budesonide DRUG

Also known as: Pulmicort

Hi-Mg + Bud; Std-Mg + Bud

Std-dose iv MgSO4 DRUG

St-Mg + P; Std-Mg + Bud

Nebulized normal saline DRUG

Hi-Mg + P; St-Mg + P

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad Medical Corporation

Doha, 3050, Qatar

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Khalid Alansari, MD

  Sidra Medicine

  STUDY DIRECTOR

Central Study Contacts

Khalid Alansari, MD

CONTACT

+974-55336166; kalansari@hamad.qa

Faten Abumusa, MD

CONTACT

+974-55312922; fmoussa@hamad.qa

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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2015
• First Posted: May 28, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: March 22, 2024

Record last verified: 2023-12

Locations

QA (1)