Magnesium Nebulization Utilization in Management of Pediatric Asthma (MAGNUMPA)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified November 2015 by The Hospital for Sick Children
Sponsor:
The Hospital for Sick Children
Collaborators:
Canadian Institutes of Health Research (CIHR)
Alberta Children's Hospital
St. Justine's Hospital
Children's Hospital of Eastern Ontario
Stollery Children's Hospital
The Children's Hospital of Winnipeg
Provincial Health Services Authority
Information provided by (Responsible Party):
Suzanne Schuh, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01429415
First received: September 2, 2011
Last updated: November 19, 2015
Last verified: November 2015
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Purpose
Acute asthma is the most common cause of pediatric hospitalizations. While the investigators know that repeat inhalations of ß2 agonists and ipratropium with early oral steroids substantially reduce hospitalizations, many children are resistant to this standard initial therapy. About a third of children remaining in moderate to severe distress after standard therapy are admitted to hospital and comprise 84% of pediatric acute asthma hospitalizations. Finding safe, non-invasive, and effective strategies to treat children resistant to standard therapy would substantially decrease hospitalizations resulting in considerable health care savings and reduction of the psycho-social burden of the disease. While studies of magnesium sulfate (Mg) given intravenously (IV) suggest that this agent can reduce hospitalizations in both adults and children resistant to standard initial therapy Nebulization is an alternate route for administering Mg. This route has the advantage of being non-invasive and is likely much safer due to lower systemic delivery. Direct delivery via nebulization allows higher Mg concentrations at the target site, the lower airways, with a smaller total drug dose. The investigators propose to conduct a properly designed study to clarify the role of nebulized Mg.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Asthma |
Drug: Magnesium Sulfate Sandoz Drug: Sodium Chloride , USP PPC |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Magnesium Nebulization Utilization in Management of Pediatric Asthma |
Resource links provided by NLM:
Further study details as provided by The Hospital for Sick Children:
Primary Outcome Measures:
- Hospitalization of Subject [ Time Frame: Up to 24 hours after treatment ] [ Designated as safety issue: No ]Defined as admission to an inpatient unit within 24hours of the start of experimental therapy due to continued/worsening distress.
Secondary Outcome Measures:
- Pediatric Respiratory Assessment Measure (PRAM) [ Time Frame: 0, 20, 40 60, 120, 180, 240 minutes post dose ] [ Designated as safety issue: No ]
- Changes in Vitals [ Time Frame: 0, 20, 40, 60, 120, 180, 240 minutes post dose ] [ Designated as safety issue: No ]Respiratory Rate, O2 saturation, Blood pressure
- Number of Salbutamol Treatments [ Time Frame: Up to 240 minutes post dose ] [ Designated as safety issue: No ]
- Medical History and Phenotype [ Time Frame: Baseline ] [ Designated as safety issue: No ]The investigators will measure hospitalization and age, gender, pre-randomization PRAM score, personal history of atopy, and "acute viral induced wheeze" phenotype. This phenotype will be defined by age less than 5 years, co-existent upper respiratory tract infection, no interval symptoms between exacerbations, no atopy
| Estimated Enrollment: | 816 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Experimental Group
Magnesium Sulfate Sandoz/PPC 600mg and Salbutamol (GlaxoSmithKline/Pharmascience) 5mg by inhalation via Aeroneb Go nebulizer (Philips) with Idehaler Pocket chamber DTF q 20 minutes, 3 treatments.
|
Drug: Magnesium Sulfate Sandoz
Each treatment will utilize 600 mg (1.2 mL) of Magnesium Sulfate Sandoz
Other Name: Magnesium Sulfate, USP 50% PPC
|
|
Placebo Comparator: Control Group
Sodium Chloride USP PPC/Omega (5.5%) placebo and salbutamol GlaxoSmithKline/Pharmascience 5 mg by inhalation via Aeroneb Go nebulizer Philips with Idehaler Pocket chamber DTF q 20 minutes, 3 treatments.
|
Drug: Sodium Chloride , USP PPC
Intervention: The control group will receive Sodium Chloride , USP PPC (1.2 mL hypertonic 5.5% saline with 5 mg Salbutamol - GlaxoSmithKline/Pharmascience
Other Name: Sodium Chloride for Injection USP Omega Laboratories Ltd.
|
Detailed Description:
The investigators plan the following specific aims:
-
Primary Objective: To examine if in children with acute asthma remaining in moderate to severe respiratory distress despite maximized initial bronchodilator and steroid therapy there is a reduction in hospitalization rate from the ED in those who receive nebulized Mg with salbutamol versus those receiving salbutamol only.
Hypothesis: The investigators hypothesize that the children with Pediatric Respiratory Assessment Measure (PRAM) ≥ 5 points after optimized initial inhaled bronchodilator and oral steroid therapies who are given nebulized Mg in addition to nebulized salbutamol will have significantly lower hospitalization rate within 24 hours of starting the study compared to those given salbutamol only.
- To compare a difference in the changes in the validated Pediatric Respiratory Assessment Measure (PRAM), respiratory rate, oxygen saturation and blood pressure from randomization baseline to 240 minutes in the two groups
- To determine if there is a significant association between the difference in the primary outcome between the groups and the patient's age, gender, baseline PRAM score, personal history of atopy and "viral-induced wheeze" phenotype.
Hypothesis(es) to be Tested In this randomized, double-blind seven-centre trial, the investigators hypothesize that children with acute asthma with a Pediatric Respiratory Assessment Measure (PRAM) of ≥ 5 points after optimized initial inhaled bronchodilator and oral steroid therapies who are given nebulized Mg in addition to nebulized salbutamol will have at least a 10% lower hospitalization rate within 24 hours of starting the study as compared to those given salbutamol only.
Eligibility| Ages Eligible for Study: | 2 Years to 17 Years (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 2-17 years of age
- Diagnosis of asthma/reactive airways/viral wheeze, defined as this diagnosis made by a physician and at least one prior acute episode of wheezing with cough or dyspnea treated with inhaled ß2 agonists or oral corticosteroids. Our study population will exclude bronchiolitis and first-time wheeze (potential alternate diagnoses).
- Persistent moderate to severe airway obstruction after 3 doses of salbutamol and ipratropium, defined as a PRAM 5 or higher. A PRAM score of 5 or more following initial therapy indicates the child has at least moderate disease severity and has a high likelihood of being hospitalized.This group of children includes 84% of all pediatric asthma hospitalizations; therefore, finding an effective therapy for this population has great potential to significantly reduce hospitalizations. (Appendix B).
Exclusion Criteria:
- No previous history of wheezing or bronchodilator therapy. Some children who present with wheezing for the first time will have other diagnoses which would not be expected to respond to Mg.
- Patients who have already received IV Mg therapy during the index visit.
- Critically ill children requiring immediate intubation. These children need immediate ICU management and hospitalization.
- Children who in the opinion of the treating physician require a chest radiograph due to atypical clinical presentation and are found to have radiologist-confirmed pneumonia. These rare patients may have to be hospitalized primarily for treatment of the infection and may not respond to magnesium.
- Known co-existent renal, chronic pulmonary, neurologic, cardiac or systemic disease. These conditions may influence the response to Mg and hospitalization.
- Known hypersensitivity to Mg sulfate.
- Patients previously enrolled in the study.
- Insufficient command of the English and or French language.
- Lack of a home or cellular telephone.
- Known allergy/sensitivity to latex.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429415
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429415
Contacts
| Contact: Judy Sweeney, RN | 416-813-7838 | judy.sweeney@sickkids.ca | |
| Contact: Henna Mian | 413-813-7654 ext 202386 | henna.mian@sickkids.ca |
Locations
| Canada, Alberta | |
| Alberta Children's Hospital | Recruiting |
| Calgary, Alberta, Canada, T3B 6A8 | |
| Contact: Jianling Xie Jianling.xie@albertahealthservices.ca | |
| Principal Investigator: Stephen Freedman, MD | |
| Principal Investigator: David Johnson, MD | |
| Stollery Hospital | Recruiting |
| Edmonton, Alberta, Canada, T6G1C9 | |
| Contact: Nadia Dow 7804920451 ndow@ualberta.ca | |
| Principal Investigator: Sarah Curtis, MD | |
| Canada, British Columbia | |
| BC Children's Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Contact: Jessie Dhillon 604 875-2345 ext 5155 jessie.dhillon@cw.bc.ca | |
| Principal Investigator: Karen Black, MD | |
| Canada, Manitoba | |
| The Manitoba Institute of Child Health | Recruiting |
| Winnipeg, Manitoba, Canada, R3E3P4 | |
| Contact: Rena Papadimitropolous 2042958660 rpapadimitropolous@mich.ca | |
| Principal Investigator: Darcy Beer, MD | |
| Canada, Ontario | |
| Children's Hospital of Eastern Ontario | Recruiting |
| Ottawa, Ontario, Canada, K1H8L1 | |
| Contact: Candice McGahern 6137377600 ext 4111 cmcgahern@cheo.on.ca | |
| Principal Investigator: Roger Zemek, MD | |
| Principal Investigator: Amy Plint, MD | |
| The Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada, M5V1X8 | |
| Contact: Judy Sweeney, RN 416-813-7838 judy.sweeney@sickkids.ca | |
| Principal Investigator: Suzanne Schuh, M.D. | |
| Canada, Quebec | |
| Ste Justine Hospital | Recruiting |
| Montreal, Quebec, Canada, H3T1C5 | |
| Contact: Maryse Lagace maryse.legace@recherche-ste-justine.qc.ca | |
| Principal Investigator: Jocelyn Gravel, MD | |
Sponsors and Collaborators
The Hospital for Sick Children
Canadian Institutes of Health Research (CIHR)
Alberta Children's Hospital
St. Justine's Hospital
Children's Hospital of Eastern Ontario
Stollery Children's Hospital
The Children's Hospital of Winnipeg
Provincial Health Services Authority
Investigators
| Principal Investigator: | Suzanne Schuh, MD | The Hospital for Sick Children |
More Information
| Responsible Party: | Suzanne Schuh, Staff Physician, The Hospital for Sick Children |
| ClinicalTrials.gov Identifier: | NCT01429415 History of Changes |
| Other Study ID Numbers: | 1000024908 |
| Study First Received: | September 2, 2011 |
| Last Updated: | November 19, 2015 |
| Health Authority: | Canada: Health Canada |
Keywords provided by The Hospital for Sick Children:
|
pediatric Acute Asthma Inhaled Magnesium |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Magnesium Sulfate Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Anti-Arrhythmia Agents Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Tocolytic Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on September 29, 2016