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.

Who is this study for? Child patients with Bronchial Asthma
What treatments are being studied? Magnesium Sulfate
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 14
Healthy Volunteers: f
View:

• 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 .

Locations
Other Locations
Qatar
Hamad Medical Corporation
RECRUITING
Doha
Contact Information
Primary
Khalid Alansari, MD
kalansari@hamad.qa
+974-55336166
Backup
Faten Abumusa, MD
fmoussa@hamad.qa
+974-55312922
Time Frame
Start Date: 2015-06
Estimated Completion Date: 2025-01
Participants
Target number of participants: 240
Treatments
Active_comparator: Hi-Mg + Bud
Group one will receive a high,then standard dose of intravenous magnesium sulfate with blinded nebulized budesonide.
Placebo_comparator: Hi-Mg + P
Group two will receive a high,then standard dose of intravenous magnesium sulfate with blinded nebulized normal saline.
Active_comparator: 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.
Placebo_comparator: 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
Related Therapeutic Areas
Sponsors
Leads: Hamad Medical Corporation

This content was sourced from clinicaltrials.gov

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