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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.

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ClinicalTrials.gov Identifier: NCT02455687
Recruitment Status : Recruiting
First Posted : May 28, 2015
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Hamad Medical Corporation

Brief Summary:

Many studies have worked on the efficacy and safety of Intravenous magnesium sulfate and inhaled steroids beside the standard treatment for patients with severe asthma attacks.

Investigators hypothesize that, two doses if intravenous magnesium sulfate with or without inhaled budesonide, would make the stay at the Pediatric emergency center (PEC) lesser,and decrease the need of being admitted to Pediatric Intensive Care Unit (PICU) for children with severe asthma attacks,compared to single dose of magnesium sulfate with or without inhaled budesonide.


Condition or disease Intervention/treatment Phase
Bronchial Asthma Drug: Intravenous magnesium sulfate Drug: Inhaled budesonide Drug: normal saline Phase 3

Detailed Description:

Patient with severe asthma attack, will be admitted to observation area in PEC and assessed for eligibility to the study by attending physician based on our study inclusion criteria.

Eligible patient will be enrolled after obtaining written consent. Patient will receive routine treatment for severe asthma attack like,inhaled bronchodilators plus intravenous steroids,and oxygen supplements if needed. Standard blood work and chest XRay test will be obtained ,and bronchial asthma severity score will be measured initially before starting treatment then at 4,8,12,24,36,48 and thereafter. The medical team as well as parents and patient will be blinded to the medications delivered. 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : June 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: 1
Group one will receive two doses of intravenous magnesium sulfate with inhaled budesonide.
Drug: Intravenous magnesium sulfate
Drug: Inhaled budesonide
Other Name: Pulmicort

Placebo Comparator: 2
Group two will receive two doses of intravenous magnesium sulfate with inhaled normal saline.
Drug: Intravenous magnesium sulfate
Drug: normal saline
Active Comparator: 3
Group three will receive single dose of intravenous magnesium sulfate plus one dose of intravenous normal saline with inhaled budesonide.
Drug: Intravenous magnesium sulfate
Drug: Inhaled budesonide
Other Name: Pulmicort

Placebo Comparator: 4
Group four will receive single dose of intravenous magnesium sulfate plus one dose of intravenous normal saline with inhaled normal saline
Drug: Intravenous magnesium sulfate
Drug: normal saline



Primary Outcome Measures :
  1. Time to medical readiness for discharge. [ Time Frame: 3 years ]
    Analyses of each of the blinded interventions will use the entire population,as this is a 2x2 factorial study.We will use retrospective stratification & quantitative interaction analysis to determine if the magnesium or magnesium placebo intervention has a different effect in the budesonide or budesonide placebo group.


Secondary Outcome Measures :
  1. Overall length of the hospital stay (days) . [ Time Frame: 3 years ]
  2. The rate of admission to pediatric intensive care unit (%) [ Time Frame: 3 years ]
  3. The rate of clinical response in severity score (%) [ Time Frame: 3 years ]
  4. The rate of revisit to pediatric emergency center (%) [ Time Frame: 3 years ]


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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Inclusion criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02455687


Contacts
Contact: Dr.khalid Alansari, Sr.consultant 55336166 kalansari@hamad.qa
Contact: Dr.Faten Abumusa, consultant 55312922 fmoussa@hamad.qa

Locations
Qatar
Hamad Medical Corporation Recruiting
Doha, Qatar, 3050
Sponsors and Collaborators
Hamad Medical Corporation

Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT02455687     History of Changes
Other Study ID Numbers: 1400046
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: March 2018

Keywords provided by Hamad Medical Corporation:
Bronchial asthma
Magnesium Sulfate
Inhaled budesonide

Additional relevant MeSH terms:
Asthma
Emergencies
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes
Budesonide
Magnesium Sulfate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Analgesics
Sensory System Agents
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants