AsthmaNCT01584726
Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma
A study testing Magnesium Sulfate in people with Asthma, run by Hamad Medical Corporation at 2 sites in Qatar.
Trial summary
The purpose of this study is to investigate the use of magnesium sulfate nebulization in patient with moderate to severe asthma exacerbation in pediatric emergency. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Asthma
- What is being tested?
- Magnesium Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesQatar
- Study dates
- Dec 2012to Dec 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric asthma patients with moderate to severe exacerbation
Who cannot join
- Known allergy to magnesium sulfate
- History of neuromuscular disease, cardiac disease, renal disease, or underlying chronic lung disease
- Use of oral steroid medication within 72 hours of presentation
- Radiographic evidence of pneumonia at presentation
- Administration of intravenous magnesium sulfate prior to study enrollment
Trial locations and contacts
2 sites in 1 country.
Qatar2 sites, 2 recruiting
- Recruiting
Hamad Medical Corporation
Doha, Qatar, 3050
KHALID AL ANSARI, MD,FRCP,FAAP, +974 44396006 ext. 6001, dkmaa@hotmail.com
WESSAM MOUHARAM, MD, +97444396022 ext. 6012, wessam_mouharam@yahoo.com
- Recruiting
Pediatric Emergency Centre
Doha, 3050
KHALID AL ANSARI, MD,FRCP,FAAP, 97444396022 ext. 6006, dkmaa@hotmail.com
WESSAM MOUHARAM, MD, 9744396022 ext. 6012, wessam_mouharam@yahoo.com
About this study
Official title: Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma Exacerbation: A Randomized, Double-Blind, Controlled Trial (RCT)
The purpose of this study is to investigate the use of magnesium sulfate nebulization in patient with moderate to severe asthma exacerbation in pediatric emergency.
Read the detailed description
the use of magnesium sulfate nebulization in patient with moderate to severe asthma exacerbation in pediatric emergency
follow asthma severity score and length of stay
- Conditions
- Asthma
- Being tested
- Magnesium Sulfate
- Keywords
- magnesium, nebulization, asthma, sulfate, children, pediatric
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
single dose of magnesium sulfate nebulization
| Study group | Role | What they receive |
|---|---|---|
| magnesium sulfate arm | Other | magnesium sulfate with standard therapy Receives: Drug: Magnesium Sulfate |
| placebo arm | No intervention | placebo with standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma significantly reduce the time to clinical readiness for discharge?
Measured: 36 months
Secondary outcomes (1)
• Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma decrease admission and readmission rate, compared to placebo
- Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma decrease PICU admission rate, compared to placebo?
- Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma improve change in asthma severity score at 4, 8, 12 hours, compared to placebo?
- Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma decrease return rate to emergency services, compared to placebo?
- Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma decrease rate of infirmray admission in follow up, compared to placebo?
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startDec 2012
- Primary completionMar 2015 (estimated)
- Study completionDec 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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- KHALID AL ANSARI, MD, Principal investigator, SENIOR CONSULTANT-HEAD OF PEDIATRIC EMERGENCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584726
- Sponsor's protocol ID
- #12095/12
- Status last verified
- Jan 2014
- First submitted
- 17 Apr 2012
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alansari K, Ahmed W, Davidson BL, Alamri M, Zakaria I, Alrifaai M. Nebulized magnesium for moderate and severe pediatric asthma: A randomized trial. Pediatr Pulmonol. 2015 Dec;50(12):1191-9. doi: 10.1002/ppul.23158. Epub 2015 Feb 4.
PubMed 25652104
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma Exacerbation: A Randomized, Double-Blind, Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT01584726
- Acronym / sponsor ID
- #12095/12
- Conditions
- Asthma
- Keywords
- magnesium, nebulization, asthma, sulfate, children, pediatric
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Apr 2012 (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 investigate the use of magnesium sulfate nebulization in patient with moderate to severe asthma exacerbation in pediatric emergency.
Detailed description
the use of magnesium sulfate nebulization in patient with moderate to severe asthma exacerbation in pediatric emergency
follow asthma severity score and length of stay
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| magnesium sulfate arm | Other | Drug: Magnesium Sulfatemagnesium sulfate with standard therapy |
| placebo arm | No intervention | –placebo with standard therapy |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric asthma patients with moderate to severe exacerbation
Key exclusion criteria (5 listed)
- Known allergy to magnesium sulfate
- History of neuromuscular disease, cardiac disease, renal disease, or underlying chronic lung disease
- Use of oral steroid medication within 72 hours of presentation
- Radiographic evidence of pneumonia at presentation
- Administration of intravenous magnesium sulfate prior to study enrollment
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 |
|---|---|---|
| Magnesium Sulfatesingle dose of magnesium sulfate nebulization | Drug | magnesium sulfate arm |
Primary outcome
Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma significantly reduce the time to clinical readiness for discharge?
Time frame: 36 months
1 secondary outcome
• Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma decrease admission and readmission rate, compared to placebo
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
- Derived from this study: PubMed 25652104Alansari K, Ahmed W, Davidson BL, Alamri M, Zakaria I, Alrifaai M. Nebulized magnesium for moderate and severe pediatric asthma: A randomized trial. Pediatr Pulmonol. 2015 Dec;50(12):1191-9. doi: 10.1002/ppul.23158. Epub 2015 Feb 4.
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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 AL ANSARI, MD principal investigator
SENIOR CONSULTANT-HEAD OF PEDIATRIC EMERGENCY
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Sulfate in people with Asthma, run by Hamad Medical Corporation at 2 sites 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 1 inclusion and 5 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 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Contact Dr. Khalid Al Ansari, MD,FRCP,FAAP (97444396001 ext. 6006, dkmaa@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Would the use of nebulized magnesium sulfate in patients with moderate to severe asthma significantly reduce the time to clinical readiness for discharge? (time frame: 36 months). 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 NCT01584726, 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 28 Jan 2014.