Bronchial AsthmaPhase 3NCT02455687
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.
A Phase 3 study testing Hi-dose iv MgSO4, Nebulized budesonide and Std-dose iv MgSO4 in people with Bronchial Asthma, run by Hamad Medical Corporation at 1 site in Qatar.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- Hi-dose iv MgSO4, Nebulized budesonide and Std-dose iv MgSO4
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteQatar
- Study dates
- Jun 2015to Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 .
Who cannot join
- Prematurity <34 weeks of gestation.
- Critically ill children requiring immediate intubation or ICU admission.
- Transfers from other institutions.
- Adverse drug reaction or allergy to budesonide,salbutamol,ipratropium bromide, prednisone, prednisolone, methylprednisolone, or magnesium sulfate.
- History of neuromuscular disease, cardiac disease, renal disease, liver disease.
- Underlying chronic lung disease.
Show all 16Show fewer
- Radiographic evidence of pneumonia or lung collapse .
- Hemodynamic instability.
- Instrumented airway or Tracheotomy.
- Colostomy or ileostomy.
- Malabsorption disorder.
- Known vitamin D deficiency.
- Receiving Milk of Magnesium for Constipation
- Chronic diarrhea (duration for 2 weeks)
- Diuretics use.
- Immunodeficiency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read the detailed description
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.
- Conditions
- Bronchial Asthma
- Being tested
- Hi-dose iv MgSO4, Nebulized budesonide, Std-dose iv MgSO4, Nebulized normal saline
- Keywords
- Bronchial Asthma, Intravenous magnesium sulfate, Inhaled budesonide
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hi-dose iv MgSO4Drug
Nebulized budesonideDrug
Also called Pulmicort
Std-dose iv MgSO4Drug
Nebulized normal salineDrug
| Study group | Role | What they receive |
|---|---|---|
| Hi-Mg + Bud | Active comparator | Group one will receive a high,then standard dose of intravenous magnesium sulfate with blinded nebulized budesonide. Receives: Drug: Hi-dose iv MgSO4; Drug: Nebulized budesonide |
| Hi-Mg + P | Placebo comparator | Group two will receive a high,then standard dose of intravenous magnesium sulfate with blinded nebulized normal saline. Receives: Drug: Hi-dose iv MgSO4; Drug: Nebulized normal saline |
| Std-Mg + Bud | Active comparator | Group three will receive a single standard dose of intravenous magnesium sulfate plus one dose of intravenous normal saline with blinded nebulized budesonide. Receives: Drug: Nebulized budesonide; Drug: Std-dose iv MgSO4 |
| St-Mg + P | Placebo comparator | Group four will receive a single dose of intravenous magnesium sulfate plus one dose of intravenous normal saline with blinded nebulized normal saline Receives: Drug: Std-dose iv MgSO4; Drug: Nebulized normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. .
Measured: 3 years
Secondary outcomes (4)
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?
Measured: 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?
Measured: 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?
Measured: 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? •
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Khalid Alansari, MD, Study director, Sidra Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455687
- Sponsor's protocol ID
- 1400046
- Status last verified
- Dec 2023
- First submitted
- 25 May 2015
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Alansari K, Moussa FA, Rasheed HA, Davidson BL, Ibrahim KY, Alrifaai M. A Pilot Placebo-Controlled Randomized Trial of Repeated High-Dose Intravenous Magnesium Sulphate and High-Dose Nebulized Budesonide for Severe Asthma in the Paediatric Emergency Department. J Paediatr Child Health. 2026 Aug 16. doi: 10.1111/jpc.70530. Online ahead of print.
PubMed 42605209
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02455687
- Acronym / sponsor ID
- 1400046
- Conditions
- Bronchial Asthma
- Keywords
- Bronchial Asthma, Intravenous magnesium sulfate, Inhaled budesonide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hi-Mg + Bud | Active comparator | Drug: Hi-dose iv MgSO4, Drug: Nebulized budesonideGroup one will receive a high,then standard dose of intravenous magnesium sulfate with blinded nebulized budesonide. |
| Hi-Mg + P | Placebo comparator | Drug: Hi-dose iv MgSO4, Drug: Nebulized normal salineGroup two will receive a high,then standard dose of intravenous magnesium sulfate with blinded nebulized normal saline. |
| Std-Mg + Bud | Active comparator | Drug: Nebulized budesonide, Drug: Std-dose iv MgSO4Group three will receive a single standard dose of intravenous magnesium sulfate plus one dose of intravenous normal saline with blinded nebulized budesonide. |
| St-Mg + P | Placebo comparator | Drug: Std-dose iv MgSO4, Drug: Nebulized normal salineGroup four will receive a single dose of intravenous magnesium sulfate plus one dose of intravenous normal saline with blinded nebulized normal saline |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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 .
Key exclusion criteria (16 listed)
- Prematurity <34 weeks of gestation.
- Critically ill children requiring immediate intubation or ICU admission.
- Transfers from other institutions.
- Adverse drug reaction or allergy to budesonide,salbutamol,ipratropium bromide, prednisone, prednisolone, methylprednisolone, or magnesium sulfate.
- History of neuromuscular disease, cardiac disease, renal disease, liver disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hi-dose iv MgSO4 | Drug | Hi-Mg + Bud, Hi-Mg + P |
| Nebulized budesonideAlso: Pulmicort | Drug | Hi-Mg + Bud, Std-Mg + Bud |
| Std-dose iv MgSO4 | Drug | St-Mg + P, Std-Mg + Bud |
| Nebulized normal saline | Drug | Hi-Mg + P, St-Mg + P |
Primary outcome
Time to medical readiness for discharge.
Time frame: 3 years
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. .
4 secondary outcomes
Overall length of the hospital stay (hours/days) .
Time frame: 3 years
The rate of admission to pediatric intensive care unit (%)
Time frame: 3 years
Comparison of clinical response in severity score (%)
Time frame: 3 years
Frequency of need for revisit and readmission to pediatric emergency center for same diagnosis(%)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Derived from this study: PubMed 42605209Alansari K, Moussa FA, Rasheed HA, Davidson BL, Ibrahim KY, Alrifaai M. A Pilot Placebo-Controlled Randomized Trial of Repeated High-Dose Intravenous Magnesium Sulphate and High-Dose Nebulized Budesonide for Severe Asthma in the Paediatric Emergency Department. J Paediatr Child Health. 2026 Aug 16. doi: 10.1111/jpc.70530. Online ahead of print.
- Individual participant dataSharing planned: Undecided
Related trials for Bronchial Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khalid Alansari, MD study director
Sidra Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hi-dose iv MgSO4, Nebulized budesonide and Std-dose iv MgSO4 in people with Bronchial Asthma, run by Hamad Medical Corporation at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khalid Alansari, MD (+974-55336166, kalansari@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to medical readiness for discharge. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02455687, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.