A Phase 3 interventional study of Hi-dose iv MgSO4 and Nebulized budesonide in Bronchial Asthma, sponsored by Hamad Medical Corporation. Recruiting at 1 site in Qatar. Open to participants aged 2 Years to 14 Years. Per ClinicalTrials.gov, last updated 2024-03-22.
Sponsored by Hamad Medical Corporation · Phase 3, Interventional, and Treatment
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.
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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 240 is above the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Hamad Medical Corporation is the lead sponsor of 139 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
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
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
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
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
Also known as: Pulmicort
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. .
Time frame: 3 years
Overall length of the hospital stay (hours/days) .
Would the two doses of intravenous magnesium sulfate with or without nebulized budesonide shorten the length of the emergency center's stay in treating severe asthma attack in children, compared to the 50 mg/kg dose with or without nebulized budesonide?
Time frame: 3 years
The rate of admission to pediatric intensive care unit (%)
Would the two doses of intravenous magnesium sulfate with or without nebulized budesonide decrease the PICU admission rate in treating severe asthma attack in children, compared to the 50 mg/kg dose with or without nebulized budesonide?
Time frame: 3 years
Comparison of clinical response in severity score (%)
Would the two doses of intravenous magnesium sulfate with or without nebulized budesonide decrease the asthma severity score at 4, 8,12,24,36,48,60,72 hours in treating severe asthma attack in children, compared to the 50 mg/kg dose with or without nebulized budesonide?
Time frame: 3 years
Frequency of need for revisit and readmission to pediatric emergency center for same diagnosis(%)
Would the two doses of intravenous magnesium sulfate with or without nebulized budesonide decrease revisit to emergency services in treating severe asthma attack in children, compared to the 50 mg/kg dose with or without nebulized budesonide? Would the two doses of intravenous magnesium sulfate with or without nebulized budesonide decrease readmission rate in treating severe asthma attack in children, compared to the 50 mg/kg dose with or without nebulized budesonide? •
Time frame: 3 years
Plan to share: Undecided
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Studies of the drug tested here: Budesonide