drugset / Trial / NCT02455687

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

Phase 3 Unknown 240 enrolled Hamad Medical Corporation
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2015-06
Primary completion
2024-12
Completion
2025-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Budesonide Small molecule Other
Comparator Magnesium Sulfate Other / unclassified Intravenous

Indications