Magnesium Nebulization Utilization in Management of Pediatric Asthma (MAGNUMPA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01429415|
Recruitment Status : Recruiting
First Posted : September 7, 2011
Last Update Posted : November 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Asthma||Drug: Magnesium Sulfate Sandoz Drug: Sodium Chloride , USP PPC||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||816 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Magnesium Nebulization Utilization in Management of Pediatric Asthma|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2019|
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.
- Hospitalization of Subject [ Time Frame: Up to 24 hours after treatment ]Defined as admission to an inpatient unit within 24hours of the start of experimental therapy due to continued/worsening distress.
- Pediatric Respiratory Assessment Measure (PRAM) [ Time Frame: 0, 20, 40 60, 120, 180, 240 minutes post dose ]
- Changes in Vitals [ Time Frame: 0, 20, 40, 60, 120, 180, 240 minutes post dose ]Respiratory Rate, O2 saturation, Blood pressure
- Number of Salbutamol Treatments [ Time Frame: Up to 240 minutes post dose ]
- Medical History and Phenotype [ Time Frame: Baseline ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429415
|Contact: Judy Sweeney, RNfirstname.lastname@example.org|
|Contact: Henna Mian||413-813-7654 ext email@example.com|
|Alberta Children's Hospital||Recruiting|
|Calgary, Alberta, Canada, T3B 6A8|
|Contact: Jianling Xie Jianling.firstname.lastname@example.org|
|Principal Investigator: Stephen Freedman, MD|
|Principal Investigator: David Johnson, MD|
|Edmonton, Alberta, Canada, T6G1C9|
|Contact: Nadia Dow 7804920451 email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Karen Black, MD|
|The Manitoba Institute of Child Health||Terminated|
|Winnipeg, Manitoba, Canada, R3E3P4|
|Children's Hospital of Eastern Ontario||Recruiting|
|Ottawa, Ontario, Canada, K1H8L1|
|Contact: Candice McGahern 6137377600 ext 4111 email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Suzanne Schuh, M.D.|
|Ste Justine Hospital||Recruiting|
|Montreal, Quebec, Canada, H3T1C5|
|Contact: Maryse Lagace email@example.com|
|Principal Investigator: Jocelyn Gravel, MD|
|Principal Investigator:||Suzanne Schuh, MD||The Hospital for Sick Children|