AsthmaPhase 2/3NCT01522040
Pilot Study of Magnesium Infusions in Pediatric Asthma
A Phase 2/3 study testing Magnesium Sulfate in people with Asthma, run by University of Louisville at 1 site in United States.
Trial summary
This is a prospective randomized pilot study that seeks to address the research question: In children with moderate-to-severe asthma, do intravenous magnesium infusions added to standard Pediatric intensive care unit (PICU)-level asthma care significantly decrease time from patient presentation until PICU discharge? Read more about this study
- Who is it for?
- Ages 2 to 20 years
- Conditions the study is for
- Asthma
- What is being tested?
- Magnesium Sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Oct 2013
- Phase
- Phase 2/3
- 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 2 years 0 days up to 20 years 364 days
- Clinical diagnosis of asthma including both of the following:
- Attending physician's primary working diagnosis is status asthmaticus
- Results of a modified International Study of Asthma and Allergies in Children (ISAAC) diagnostic questionnaire consistent with an asthma diagnosis
- Planned PICU admission for moderate-to-severe asthma exacerbation persisting despite standard first-tier therapy (systemic corticosteroids and at least a one-hour treatment with nebulized albuterol/ipratroprium or equivalent) as evidenced by an asthma score of 7 or greater
- IV access or equivalent
- Ability to understand and give informed consent/assent in English
Who cannot join
- Prior enrollment in this study
- Prior adverse reactions to magnesium
- Use of systemic corticosteroids or magnesium in preceding 2 weeks, or administered at a transferring facility more than 3 hours prior to enrollment
- Admission for inpatient asthma care in preceding 2 weeks
- Hemodynamic instability, impending respiratory failure or intubation
- Inability in children age 7 years or older to give assent due to a developmental delay or altered mental status
Show all 9Show fewer
- Significant renal or cardiac disease
- Sickle cell anemia
- Significant, active non-asthma pulmonary disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Kosair Children's Hospital
Louisville, Kentucky, 40204
About this study
Official title: A Pilot Study of Magnesium Infusions (Drips) for Moderate-to-Severe Pediatric Asthma Exacerbations
This is a prospective randomized pilot study that seeks to address the research question: In children with moderate-to-severe asthma, do intravenous magnesium infusions added to standard Pediatric intensive care unit (PICU)-level asthma care significantly decrease time from patient presentation until PICU discharge?
Read the detailed description
This study will be a double-blind, prospective randomized pilot study. Subjects will be randomized on a 1:1 basis to receive routine asthma care with or without a magnesium drip.
- Conditions
- Asthma
- Being tested
- Magnesium Sulfate, Placebo
- Keywords
- Asthma, Magnesium, Adrenergic Receptor
- 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
Continuous magnesium drip, titrated to effect until patient's symptoms improve
PlaceboDrug
Simple saline drip, without active drug
| Study group | Role | What they receive |
|---|---|---|
| Magnesium | Active comparator | Half the enrolled subjects will be randomized to receive active drug, a magnesium infusion. Receives: Drug: Magnesium Sulfate |
| Control | Placebo comparator | Half the subjects will be randomized to receive a drip that does not have active drug (magnesium sulfate). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to discharge
The primary outcome for this study is elapsed time from emergency department (ED) presentation to readiness for PICU discharge.
Measured: Duration of hospital stay, typically 3-5 days
Secondary outcomes (1)
Beta receptor haplotype
The subject's genetic haplotype for beta adrenergic receptor. It will be determined by blood test during their admission in the hospital and enrollment on the study protocol.
Measured: Once on enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2013
- Study completionOct 2013
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 University of LouisvilleThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Cross, University of Louisville
- Investigators
- Keith Cross, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522040
- Sponsor's protocol ID
- 11.0641
- Status last verified
- Mar 2017
- First submitted
- 24 Jan 2012
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Magnesium Infusions (Drips) for Moderate-to-Severe Pediatric Asthma Exacerbations
- ClinicalTrials.gov ID
- NCT01522040
- Acronym / sponsor ID
- 11.0641
- Conditions
- Asthma
- Keywords
- Asthma, Magnesium, Adrenergic Receptor
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 31 Jan 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.
This is a prospective randomized pilot study that seeks to address the research question: In children with moderate-to-severe asthma, do intravenous magnesium infusions added to standard Pediatric intensive care unit (PICU)-level asthma care significantly decrease time from patient presentation until PICU discharge?
Detailed description
This study will be a double-blind, prospective randomized pilot study. Subjects will be randomized on a 1:1 basis to receive routine asthma care with or without a magnesium drip.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium | Active comparator | Drug: Magnesium SulfateHalf the enrolled subjects will be randomized to receive active drug, a magnesium infusion. |
| Control | Placebo comparator | Drug: PlaceboHalf the subjects will be randomized to receive a drip that does not have active drug (magnesium sulfate). |
Who may qualify
- Ages
- 2 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age 2 years 0 days up to 20 years 364 days
- Clinical diagnosis of asthma including both of the following:
- Planned PICU admission for moderate-to-severe asthma exacerbation persisting despite standard first-tier therapy (systemic corticosteroids and at least a one-hour treatment with nebulized albuterol/ipratroprium or equivalent) as evidenced by an asthma score of 7 or greater
- IV access or equivalent
- Ability to understand and give informed consent/assent in English
Key exclusion criteria (9 listed)
- Prior enrollment in this study
- Prior adverse reactions to magnesium
- Use of systemic corticosteroids or magnesium in preceding 2 weeks, or administered at a transferring facility more than 3 hours prior to enrollment
- Admission for inpatient asthma care in preceding 2 weeks
- Hemodynamic instability, impending respiratory failure or intubation
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 SulfateContinuous magnesium drip, titrated to effect until patient's symptoms improve | Drug | Magnesium |
| PlaceboSimple saline drip, without active drug | Drug | Control |
Primary outcome
Time to discharge
Time frame: Duration of hospital stay, typically 3-5 days
The primary outcome for this study is elapsed time from emergency department (ED) presentation to readiness for PICU discharge.
1 secondary outcome
Beta receptor haplotype
Time frame: Once on enrollment
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 30 Mar 2017.
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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.
Keith Cross, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Magnesium Sulfate in people with Asthma, run by University of Louisville 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 7 inclusion and 9 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 30 Mar 2017. 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. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Time to discharge (time frame: Duration of hospital stay, typically 3-5 days). 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 30 Mar 2017.