AsthmaPhase 3NCT00522444
Nebulized Magnesium Sulfate in Pediatric Asthma
A Phase 3 study testing Nebulized Magnesium Sulfate and Nebulized normal saline in people with Asthma, run by Children's Hospital Medical Center, Cincinnati.
Trial summary
Nebulized Magnesium Sulfate has been shown to be of benefit in adults with acute asthma exacerbations, though limited work has been done in the pediatric population. Current therapeutic questions include the effect of more than one dose of nebulized magnesium, the possibility of a sustained effect (greater than 20… 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 and Nebulized normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Sep 2013
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric Patients ages 7-18 years old
- Parental report of previous history of asthma or wheezing episode documented by physician at least 3 months prior to enrollment
- Acute Asthma exacerbation as defined by attending physician and asthma score (PASS) of greater than or equal to 2 after initial albuterol treatment
Who cannot join
- Temperature in triage of greater than or equal to 39 degrees Celsius
- Systemic corticosteroids in past 72 hours
- Medical history significant for cardiac, renal, or malignant disease, or bronchopulmonary dysplasia or cystic fibrosis
- Patients whose care is initiated in the trauma bay due to need for rapid stabilization or any patient deemed too ill to participate by the attending ED physician
- Altered Mental Status (Glasgow Coma Score of < 15)
- Asthma Score (PASS) of > 6, and in conjunction with FEV1 < 45% predicted
Show all 11Show fewer
- Oxygen saturation < 90% while on 6L of 100% oxygen via face mask
- Respiratory distress occurring after FEV1 attempt in conjunction with any increase in asthma score (PASS) from previous score
- Enrollment in any other research study in the previous 30 days
- Previous enrollment in this RCT
- Initial administration of continuously nebulized albuterol or dose of IV Magnesium Sulfate in the ED
About this study
Official title: Nebulized Magnesium Sulfate Compared to Saline in Addition to Albuterol and Ipratropium Treatments in Moderate to Severe Pediatric Asthmatic Patients: A Randomized Controlled Clinical Trial
Nebulized Magnesium Sulfate has been shown to be of benefit in adults with acute asthma exacerbations, though limited work has been done in the pediatric population. Current therapeutic questions include the effect of more than one dose of nebulized magnesium, the possibility of a sustained effect (greater than 20 minutes) after a treatment, the potential benefit in children younger than 5 years of age, and the use of an asthma score to re-assess patients after treatment with this medication. The purpose of this double-blind randomized placebo-controlled clinical trial is the evaluate the effect of multiple doses of nebulized magnesium sulfate versus saline in addition to standard asthma therapy on clinical asthma score and FEV1 in children 7 to 18 years of age with a moderate to severe acute asthma exacerbation. Our hypothesis is that nebulized magnesium sulfate, when added to traditional bronchodilator therapy, will improve acute asthma exacerbations more rapidly than standard therapy alone. The primary outcomes are asthma score and FEV1 values obtained after two nebulized magnesium sulfate compared to placebo treatments. This therapy will be supplemental to standard therapy of albuterol and ipratropium nebulized treatments and systemic corticosteroids. The secondary outcome is patient disposition (discharge home or hospitalization). Patients with known asthma will be approached for enrollment and informed consent obtained if the asthma score after the first albuterol treatment is "2" or greater. One hundred-seventy patients will be enrolled and randomized to either the treatment group or the placebo group. The change from baseline in asthma scores and FEV1 values will be compared among the control and treatment groups to assess for any benefit of the addition of nebulized magnesium sulfate to the treatment regimen.
Read the detailed description
Acute asthma exacerbations continue to be a growing heath care dilemma, even as increased efforts are made in preventing such exacerbations. The standard of care for such exacerbations typically involves inhaled beta-agonist therapy and oral steroids. Patients who are refractory to these treatments may require intravenous access for the purposes of delivering additional medications, including magnesium sulfate. Intravenous magnesium sulfate has been shown to be beneficial in moderate and severe acute asthma exacerbations in adults and children, and new research indicates a trend toward benefits from nebulized magnesium sulfate, even in those with a mild exacerbation of asthma. Delivery of magnesium sulfate via the inhalation route is less invasive than the intravenous route, which is preferable in the pediatric population. The possible short-term benefits of the nebulized form of magnesium sulfate include decreased ED length of stay and prevention of admission to the intensive care unit if the patient must be hospitalized for further treatments. The specific aim of this study is to evaluate the effect of the addition of nebulized magnesium sulfate to our standard emergency department therapy by comparing the change from baseline of asthma scores and FEV1 (forced expiratory volume in 1 second) in children with acute asthma exacerbations.
- Conditions
- Asthma
- Being tested
- Nebulized Magnesium Sulfate, Nebulized normal saline
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized Magnesium SulfateDrug
Also called magnesium heptahydrate
6.3% solution of magnesium heptahydrate, which is equivalent to 3.18% anhydrous magnesium sulfate
Nebulized normal salineOther
standard of care
| Study group | Role | What they receive |
|---|---|---|
| nebulized magnesium sulfate | Experimental | 6.3% solution of magnesium heptahydrate, which is equivalent to 3.18% anhydrous magnesium sulfate Receives: Drug: Nebulized Magnesium Sulfate |
| normal saline nebulization | Placebo comparator | standard of care Receives: Other: Nebulized normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change is PASS Asthma Score
The primary outcome event for the assessment of efficacy in all patients is the change in PASS asthma score from Time Zero to Times One and Two.
Measured: through emergency admission, an average of less than 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurie Johnson, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522444
- Sponsor's protocol ID
- 2008-0431
- Status last verified
- Sep 2020
- First submitted
- 28 Aug 2007
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Magnesium Sulfate Compared to Saline in Addition to Albuterol and Ipratropium Treatments in Moderate to Severe Pediatric Asthmatic Patients: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00522444
- Acronym / sponsor ID
- 2008-0431
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Sep 2007 (actual)
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 29 Aug 2007 (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.
Nebulized Magnesium Sulfate has been shown to be of benefit in adults with acute asthma exacerbations, though limited work has been done in the pediatric population. Current therapeutic questions include the effect of more than one dose of nebulized magnesium, the possibility of a sustained effect (greater than 20 minutes) after a treatment, the potential benefit in children younger than 5 years of age, and the use of an asthma score to re-assess patients after treatment with this medication. The purpose of this double-blind randomized placebo-controlled clinical trial is the evaluate the effect of multiple doses of nebulized magnesium sulfate versus saline in addition to standard asthma therapy on clinical asthma score and FEV1 in children 7 to 18 years of age with a moderate to severe acute asthma exacerbation. Our hypothesis is that nebulized magnesium sulfate, when added to traditional bronchodilator therapy, will improve acute asthma exacerbations more rapidly than standard therapy alone. The primary outcomes are asthma score and FEV1 values obtained after two nebulized magnesium sulfate compared to placebo treatments. This therapy will be supplemental to standard therapy of albuterol and ipratropium nebulized treatments and systemic corticosteroids. The secondary outcome is patient disposition (discharge home or hospitalization). Patients with known asthma will be approached for enrollment and informed consent obtained if the asthma score after the first albuterol treatment is "2" or greater. One hundred-seventy patients will be enrolled and randomized to either the treatment group or the placebo group. The change from baseline in asthma scores and FEV1 values will be compared among the control and treatment groups to assess for any benefit of the addition of nebulized magnesium sulfate to the treatment regimen.
Detailed description
Acute asthma exacerbations continue to be a growing heath care dilemma, even as increased efforts are made in preventing such exacerbations. The standard of care for such exacerbations typically involves inhaled beta-agonist therapy and oral steroids. Patients who are refractory to these treatments may require intravenous access for the purposes of delivering additional medications, including magnesium sulfate. Intravenous magnesium sulfate has been shown to be beneficial in moderate and severe acute asthma exacerbations in adults and children, and new research indicates a trend toward benefits from nebulized magnesium sulfate, even in those with a mild exacerbation of asthma. Delivery of magnesium sulfate via the inhalation route is less invasive than the intravenous route, which is preferable in the pediatric population. The possible short-term benefits of the nebulized form of magnesium sulfate include decreased ED length of stay and prevention of admission to the intensive care unit if the patient must be hospitalized for further treatments. The specific aim of this study is to evaluate the effect of the addition of nebulized magnesium sulfate to our standard emergency department therapy by comparing the change from baseline of asthma scores and FEV1 (forced expiratory volume in 1 second) in children with acute asthma exacerbations.
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 |
|---|---|---|
| nebulized magnesium sulfate | Experimental | Drug: Nebulized Magnesium Sulfate6.3% solution of magnesium heptahydrate, which is equivalent to 3.18% anhydrous magnesium sulfate |
| normal saline nebulization | Placebo comparator | Other: Nebulized normal salinestandard of care |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pediatric Patients ages 7-18 years old
- Parental report of previous history of asthma or wheezing episode documented by physician at least 3 months prior to enrollment
- Acute Asthma exacerbation as defined by attending physician and asthma score (PASS) of greater than or equal to 2 after initial albuterol treatment
Key exclusion criteria (11 listed)
- Temperature in triage of greater than or equal to 39 degrees Celsius
- Systemic corticosteroids in past 72 hours
- Medical history significant for cardiac, renal, or malignant disease, or bronchopulmonary dysplasia or cystic fibrosis
- Patients whose care is initiated in the trauma bay due to need for rapid stabilization or any patient deemed too ill to participate by the attending ED physician
- Altered Mental Status (Glasgow Coma Score of < 15)
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: magnesium heptahydrate6.3% solution of magnesium heptahydrate, which is equivalent to 3.18% anhydrous magnesium sulfate | Drug | nebulized magnesium sulfate |
| Nebulized normal salinestandard of care | Other | normal saline nebulization |
Primary outcome
Change is PASS Asthma Score
Time frame: through emergency admission, an average of less than 1 day
The primary outcome event for the assessment of efficacy in all patients is the change in PASS asthma score from Time Zero to Times One and Two.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
Related trials for 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.
Laurie Johnson, MD principal investigator
Children's Hospital Medical Center, Cincinnati
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nebulized Magnesium Sulfate and Nebulized normal saline in people with Asthma, run by Children's Hospital Medical Center, Cincinnati.
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 3 inclusion and 11 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: withdrawn, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 is PASS Asthma Score (time frame: through emergency admission, an average of less than 1 day). 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 7 Sep 2020.