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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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2024-03-22

No results posted yet for this study

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

Interventions

DRUG

Hi-dose iv MgSO4

DRUG

Nebulized budesonide

DRUG

Std-dose iv MgSO4

DRUG

Nebulized normal saline

Sponsors & Collaborators

  • Hamad Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Khalid Alansari, MD · Sidra Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2024-12-31
Completion
2025-01-31

Countries

  • Qatar

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02455687 on ClinicalTrials.gov