AsthmaPhase 4NCT01515995
Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma Exacerbation
A Phase 4 study testing Nebulized magnesium sulfate in people with Asthma, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of nebulized magnesium sulfate as a vehicle for albuterol in children with moderate to severe asthma exacerbation. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- Nebulized magnesium sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Oct 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients age ≥ seven years
- Previous diagnosis of asthma or previous episode of wheezing treated with beta-agonist medication
- Able to complete bedside spirometry
- FEV1 < 70% predicted
Who cannot join
- Known allergy to magnesium sulfate
- Known contra-indication to albuterol
- Respiratory distress occurring as a result of bedside spirometry
- History of neuromuscular disease, cardiac disease, renal disease, or underlying chronic lung disease
- Pregnancy
- Use of oral steroid medication within 72 hours of presentation
Show all 10Show fewer
- Radiographic evidence of pneumonia at presentation
- Intubation during the current encounter prior to study enrollment
- Administration of intravenous magnesium sulfate prior to study enrollment
- Prior participation in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Medical Center Dallas
Dallas, Texas, 75390
About this study
Official title: Nebulized Magnesium Sulfate Versus Normal Saline as a Vehicle for Albuterol in Children With Moderate to Severe Asthma Exacerbation: a Randomized Controlled Trial
The purpose of this study is to evaluate the effectiveness of nebulized magnesium sulfate as a vehicle for albuterol in children with moderate to severe asthma exacerbation.
Read the detailed description
Patients presenting to the Emergency Department for acute asthma exacerbation will receive standard care of up to three doses of albuterol and ipratropium bromide plus oral steroid medication. Those seven years of age and older who require further treatment will be screened for eligibility. Eligibility screening will comprise measurement of forced expiratory volume in one second (FEV1) with a bedside spirometer by a respiratory therapist. Children under the age of seven are generally unable to complete spirometry maneuvers and will thus be excluded. The Pediatric Asthma Severity Score (PASS) will also be noted by a respiratory therapist. Patients able to complete spirometry testing and with an FEV1 less than 70% of predicted (the definition of moderate asthma exacerbation) will be enrolled. Enrolled patients will be randomized to receive either Children's Medical Center standard care of 15 mg albuterol diluted in 22 ml of normal saline or the study intervention of 15 mg of albuterol diluted in 22 ml of magnesium sulfate solution. This solution will be prepared at the time of use by a pharmacist in the Emergency Department and will consist of 22 ml of a commercially available 40 mg/ml magnesium sulfate solution (880 mg). The nebulizer treatment will be given over approximately one hour via a large volume nebulizer at 25 ml/hr. Physicians, nurses, and respiratory therapists will be blinded to the diluent used. Vital signs will be noted at baseline. Heart rate, heart rhythm, respiratory rate, and pulse oximetry will be monitored continuously while blood pressure will be measured at baseline and every 15 minutes during study medication administration. The study physician, treating physician, and/or bedside nurse will monitor these values for any clinically significant changes. At the end of the 15 mg albuterol treatment FEV1 and PASS will again be noted. Any further treatments needed, as determined by the treating physician, will be given following Children's Medical Center standard of care. At the discretion of the treating physician intravenous magnesium sulfate may be used post study intervention. The dose used for study participants will be the Children's Medical Center standard dose of 75 mg/kg (max 3 g) minus 880 mg to avoid the risk of magnesium sulfate overdose. Further treatments and patient disposition will be observed by study personnel and noted. Bounce-back rates will be collected by review of enrolled patients' medical record.
- Conditions
- Asthma
- Being tested
- Nebulized magnesium sulfate
- Keywords
- Magnesium sulfate, Childhood asthma, Emergency department
- Medical subject headings
- Asthma, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized magnesium sulfateDrug
Also called Inhaled magnesium sulfate
15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour
Versus
15 mg albuterol in 22 ml of normal saline via nebulizer over one hour
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulfate group | Experimental | 15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour Receives: Drug: Nebulized magnesium sulfate |
| Normal Saline group | Active comparator | 15 mg albuterol in 22 ml of normal saline solution via nebulizer over one hour Receives: Drug: Nebulized magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Forced Expiratory Volume in One Second (FEV1) %
Change in forced expiratory volume in one second (FEV1) as measured by bedside spirometry before and after study intervention.
Measured: Baseline and one hour after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Badawy, MD, Study director, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515995
- Sponsor's protocol ID
- ( STU 072011-043)
- Status last verified
- Jan 2019
- First submitted
- 11 Jan 2012
- Last updated
- 21 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Magnesium Sulfate Versus Normal Saline as a Vehicle for Albuterol in Children With Moderate to Severe Asthma Exacerbation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01515995
- Acronym / sponsor ID
- ( STU 072011-043)
- Conditions
- Asthma
- Keywords
- Magnesium sulfate, Childhood asthma, Emergency department
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 24 Jan 2012 (estimated)
- Results
- Posted 21 Feb 2019
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 evaluate the effectiveness of nebulized magnesium sulfate as a vehicle for albuterol in children with moderate to severe asthma exacerbation.
Detailed description
Patients presenting to the Emergency Department for acute asthma exacerbation will receive standard care of up to three doses of albuterol and ipratropium bromide plus oral steroid medication. Those seven years of age and older who require further treatment will be screened for eligibility. Eligibility screening will comprise measurement of forced expiratory volume in one second (FEV1) with a bedside spirometer by a respiratory therapist. Children under the age of seven are generally unable to complete spirometry maneuvers and will thus be excluded. The Pediatric Asthma Severity Score (PASS) will also be noted by a respiratory therapist. Patients able to complete spirometry testing and with an FEV1 less than 70% of predicted (the definition of moderate asthma exacerbation) will be enrolled. Enrolled patients will be randomized to receive either Children's Medical Center standard care of 15 mg albuterol diluted in 22 ml of normal saline or the study intervention of 15 mg of albuterol diluted in 22 ml of magnesium sulfate solution. This solution will be prepared at the time of use by a pharmacist in the Emergency Department and will consist of 22 ml of a commercially available 40 mg/ml magnesium sulfate solution (880 mg). The nebulizer treatment will be given over approximately one hour via a large volume nebulizer at 25 ml/hr. Physicians, nurses, and respiratory therapists will be blinded to the diluent used. Vital signs will be noted at baseline. Heart rate, heart rhythm, respiratory rate, and pulse oximetry will be monitored continuously while blood pressure will be measured at baseline and every 15 minutes during study medication administration. The study physician, treating physician, and/or bedside nurse will monitor these values for any clinically significant changes. At the end of the 15 mg albuterol treatment FEV1 and PASS will again be noted. Any further treatments needed, as determined by the treating physician, will be given following Children's Medical Center standard of care. At the discretion of the treating physician intravenous magnesium sulfate may be used post study intervention. The dose used for study participants will be the Children's Medical Center standard dose of 75 mg/kg (max 3 g) minus 880 mg to avoid the risk of magnesium sulfate overdose. Further treatments and patient disposition will be observed by study personnel and noted. Bounce-back rates will be collected by review of enrolled patients' medical record.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulfate group | Experimental | Drug: Nebulized magnesium sulfate15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour |
| Normal Saline group | Active comparator | Drug: Nebulized magnesium sulfate15 mg albuterol in 22 ml of normal saline solution via nebulizer over one hour |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients age ≥ seven years
- Previous diagnosis of asthma or previous episode of wheezing treated with beta-agonist medication
- Able to complete bedside spirometry
- FEV1 < 70% predicted
Key exclusion criteria (10 listed)
- Known allergy to magnesium sulfate
- Known contra-indication to albuterol
- Respiratory distress occurring as a result of bedside spirometry
- History of neuromuscular disease, cardiac disease, renal disease, or underlying chronic lung disease
- Pregnancy
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 |
|---|---|---|
| Nebulized magnesium sulfateAlso: Inhaled magnesium sulfate15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour Versus 15 mg albuterol in 22 ml of normal saline via nebulizer over one hour | Drug | Magnesium sulfate group, Normal Saline group |
Primary outcome
Change in Forced Expiratory Volume in One Second (FEV1) %
Time frame: Baseline and one hour after treatment
Change in forced expiratory volume in one second (FEV1) as measured by bedside spirometry before and after study intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mohamed Badawy, MD study director
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nebulized magnesium sulfate in people with Asthma, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 10 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: finished, as of the sponsor's last update on 21 Feb 2019. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Forced Expiratory Volume in One Second (FEV1) % (time frame: Baseline and one hour after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2019.