Acute Severe AsthmaNCT02112305
Compare Efficacy Nebulized and Intravenous Magnesium Sulphate in Thai Children
A study testing isotonic magnesium sulphate and 50% magnesium sulphate in people with Acute Severe Asthma, run by Queen Sirikit National Institute of Child Health at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether nebulized magnesium sulphate is effective in the treatment of acute severe asthma when comparison with intravenous magnesium sulphate Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Acute Severe Asthma
- What is being tested?
- isotonic magnesium sulphate and 50% magnesium sulphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2014to May 2015
- Phase
- Interventional
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children age 2-15 years presenting with severe asthma or persistent wheeze without responding to conventional therapy
Who cannot join
- chronic lung disease
- history of adverse reaction form magnesium sulphate
- life threatening condition
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Queen Sirikit National Institute of Child Health
Bangkok, 10400
About this study
Official title: Comparison Efficacy of Nebulized Magnesium Sulphate to Intravenous Magnesium Sulphate in Children With Severe Acute Asthma
The purpose of this study is to determine whether nebulized magnesium sulphate is effective in the treatment of acute severe asthma when comparison with intravenous magnesium sulphate
Read the detailed description
Intervention: At randomization eligible patients were allocated to receive 2.5ml of isotonic magnesium sulphate (150 mg,245 mmol/L) on three occasional at 20 minutes interval or standard treatment 50 mg/kg intravenous magnesium sulphate. The asthma severity score was record at 0,20,40,60,120,180,240 minutes post randomization. Adverse event were assessed at each assessment point. Patients were followed up until discharge from hospital to collect secondary outcome data.
- Conditions
- Acute Severe Asthma
- Being tested
- isotonic magnesium sulphate, 50% magnesium sulphate
- Keywords
- Magnesium sulphate nebulized
- Medical subject headings
- Status Asthmaticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isotonic magnesium sulphateDrug
Also called magnesium sulfate
2.5 ml of isotonic magnesium sulphate (150 mg, 245 mmol/L) NB on three occasional at 20 minutes interval
50% magnesium sulphateDrug
Also called magnesium sulfate
magnesium sulphate 50mg/kg/dose intravenous drip in 20 minutes for one dose
| Study group | Role | What they receive |
|---|---|---|
| isotonic magnesium sulphate | Experimental | 2.5 ml of isotonic magnesium sulphate (150 mg, 245 mmol/L) on three occasional at 20 minutes interval Receives: Drug: isotonic magnesium sulphate |
| 50% magnesium sulphate | Active comparator | magnesium sulphate 50mg/kg/dose intravenous drip in 20 minutes for one dose Receives: Drug: 50% magnesium sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma severity score
Measured: 60 minute
Secondary outcomes (1)
Length of stay in the hospital
Measured: within 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (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 Acute Severe AsthmaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Sirikit National Institute of Child Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tassalapa Daengsuwan, Queen Sirikit National Institute of Child Health
- Investigators
- Tassalapa Daengsuwan, Pediatrician, Study director, Queen Sirikit National Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112305
- Sponsor's protocol ID
- EC 104/2557
- Status last verified
- Nov 2014
- First submitted
- 4 Apr 2014
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Powell CV, Kolamunnage-Dona R, Lowe J, Boland A, Petrou S, Doull I, Hood K, Williamson PR; MAGNETIC study group. MAGNEsium Trial In Children (MAGNETIC): a randomised, placebo-controlled trial and economic evaluation of nebulised magnesium sulphate in acute severe asthma in children. Health Technol Assess. 2013 Oct;17(45):v-vi, 1-216. doi: 10.3310/hta17450.
PubMed 24144222
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Efficacy of Nebulized Magnesium Sulphate to Intravenous Magnesium Sulphate in Children With Severe Acute Asthma
- ClinicalTrials.gov ID
- NCT02112305
- Acronym / sponsor ID
- EC 104/2557
- Conditions
- Acute Severe Asthma
- Keywords
- Magnesium sulphate nebulized
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Queen Sirikit National Institute of Child HealthOther government
- Study start
- Jan 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 11 Apr 2014 (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.
The purpose of this study is to determine whether nebulized magnesium sulphate is effective in the treatment of acute severe asthma when comparison with intravenous magnesium sulphate
Detailed description
Intervention: At randomization eligible patients were allocated to receive 2.5ml of isotonic magnesium sulphate (150 mg,245 mmol/L) on three occasional at 20 minutes interval or standard treatment 50 mg/kg intravenous magnesium sulphate. The asthma severity score was record at 0,20,40,60,120,180,240 minutes post randomization. Adverse event were assessed at each assessment point. Patients were followed up until discharge from hospital to collect secondary outcome data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| isotonic magnesium sulphate | Experimental | Drug: isotonic magnesium sulphate2.5 ml of isotonic magnesium sulphate (150 mg, 245 mmol/L) on three occasional at 20 minutes interval |
| 50% magnesium sulphate | Active comparator | Drug: 50% magnesium sulphatemagnesium sulphate 50mg/kg/dose intravenous drip in 20 minutes for one dose |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children age 2-15 years presenting with severe asthma or persistent wheeze without responding to conventional therapy
Key exclusion criteria (3 listed)
- chronic lung disease
- history of adverse reaction form magnesium sulphate
- life threatening condition
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 |
|---|---|---|
| isotonic magnesium sulphateAlso: magnesium sulfate2.5 ml of isotonic magnesium sulphate (150 mg, 245 mmol/L) NB on three occasional at 20 minutes interval | Drug | isotonic magnesium sulphate |
| 50% magnesium sulphateAlso: magnesium sulfatemagnesium sulphate 50mg/kg/dose intravenous drip in 20 minutes for one dose | Drug | 50% magnesium sulphate |
Primary outcome
Asthma severity score
Time frame: 60 minute
1 secondary outcome
Length of stay in the hospital
Time frame: within 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
- Results publication: PubMed 24144222Powell CV, Kolamunnage-Dona R, Lowe J, Boland A, Petrou S, Doull I, Hood K, Williamson PR; MAGNETIC study group. MAGNEsium Trial In Children (MAGNETIC): a randomised, placebo-controlled trial and economic evaluation of nebulised magnesium sulphate in acute severe asthma in children. Health Technol Assess. 2013 Oct;17(45):v-vi, 1-216. doi: 10.3310/hta17450.
Related trials for Acute Severe Asthma
Not yet recruiting
Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Pediatric Asthma, Acute Asthma
Recruiting
Characterization of Natural Killer Cells in Severe Asthma Patients in Comparison With Control Subjects
Asthma Acute
RecruitingPhase 2
Nebulized Ketamine Plus Standard Care vs. Standard Care Alone in Moderate to Severe Asthma Exacerbations
Asthma Acute, Asthma Attack
Not yet recruiting
Efficacy of High-Dose Continuous Intravenous Magnesium Sulfate Infusion vs Standard Intravenous Magnesium Sulfate Therapy in Status Asthmaticus in the ED
Asthma Exacerbation, Emergency Department
RecruitingPhase 2
Pediatric Asthma Trial of Corticosteroid Heterogeneity (PATCH): Trial of Dexamethasone Versus Methylprednisolone for Pediatric Critical Asthma
Asthma (Diagnosis)
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.
Tassalapa Daengsuwan, Pediatrician study director
Queen Sirikit National Institute of Child Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isotonic magnesium sulphate and 50% magnesium sulphate in people with Acute Severe Asthma, run by Queen Sirikit National Institute of Child Health at 1 site in Thailand.
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 1 inclusion and 3 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 18 Nov 2014. 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 Thailand. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma severity score (time frame: 60 minute). 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 NCT02112305, 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 18 Nov 2014.