Magnesium Nebulization Utilization in Management of Pediatric Asthma

NCT01429415 | Completed Phase 2 DMC

• 1 other identifier: 1000024908
• Study Type: interventional
• Target: 818
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Acute Asthma

Keywords

pediatric; Acute Asthma; Inhaled Magnesium

Outcome Measures

Primary Outcomes (1)

• Hospitalization of Subject

  Defined as admission to an inpatient unit within 24hours of the start of experimental therapy due to continued/worsening distress.

  Up to 24 hours after treatment

Secondary Outcomes (4)

• Pediatric Respiratory Assessment Measure (PRAM)

  0, 20, 40 60, 120, 180, 240 minutes post dose

• Changes in Vitals

  0, 20, 40, 60, 120, 180, 240 minutes post dose

• Number of Salbutamol Treatments

  Up to 240 minutes post dose

• Medical History and Phenotype

  Baseline

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

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

Interventions

Magnesium Sulfate Sandoz DRUG

Each treatment will utilize 600 mg (1.2 mL) of Magnesium Sulfate Sandoz

Also known as: Magnesium Sulfate, USP 50% PPC

Experimental Group

Sodium Chloride , USP PPC DRUG

Intervention: The control group will receive Sodium Chloride , USP PPC (1.2 mL hypertonic 5.5% saline with 5 mg Salbutamol - GlaxoSmithKline/Pharmascience

Also known as: Sodium Chloride for Injection USP Omega Laboratories Ltd.

Control Group

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 (as per site specific standard of care guidelines) -, 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Alberta Children's Hospital: collaborator
• St. Justine's Hospital: collaborator
• Children's Hospital of Eastern Ontario: collaborator
• Stollery Children's Hospital: collaborator
• The Children's Hospital of Winnipeg: collaborator
• Provincial Health Services Authority British Columbia: collaborator

Study Sites (7)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Stollery Hospital

Edmonton, Alberta, T6G1C9, Canada

Location

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

The Manitoba Institute of Child Health

Winnipeg, Manitoba, R3E3P4, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H8L1, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5V1X8, Canada

Location

Ste Justine Hospital

Montreal, Quebec, H3T1C5, Canada

Location

Related Publications (3)

• Schuh S, Freedman SB, Zemek R, Plint AC, Johnson DW, Ducharme F, Gravel J, Thompson G, Curtis S, Stephens D, Coates AL, Black KJ, Beer D, Sweeney J, Rumantir M, Finkelstein Y; Pediatric Emergency Research Canada. Association Between Intravenous Magnesium Therapy in the Emergency Department and Subsequent Hospitalization Among Pediatric Patients With Refractory Acute Asthma: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2117542. doi: 10.1001/jamanetworkopen.2021.17542.

  PMID: 34279646 DERIVED

• Schuh S, Sweeney J, Rumantir M, Coates AL, Willan AR, Stephens D, Atenafu EG, Finkelstein Y, Thompson G, Zemek R, Plint AC, Gravel J, Ducharme FM, Johnson DW, Black K, Curtis S, Beer D, Klassen TP, Nicksy D, Freedman SB; Pediatric Emergency Research Canada (PERC) Network. Effect of Nebulized Magnesium vs Placebo Added to Albuterol on Hospitalization Among Children With Refractory Acute Asthma Treated in the Emergency Department: A Randomized Clinical Trial. JAMA. 2020 Nov 24;324(20):2038-2047. doi: 10.1001/jama.2020.19839.

  PMID: 33231663 DERIVED

• Schuh S, Sweeney J, Freedman SB, Coates AL, Johnson DW, Thompson G, Gravel J, Ducharme FM, Zemek R, Plint AC, Beer D, Klassen T, Curtis S, Black K, Nicksy D, Willan AR; Pediatric Emergency Research Canada Group. Magnesium nebulization utilization in management of pediatric asthma (MagNUM PA) trial: study protocol for a randomized controlled trial. Trials. 2016 May 24;17(1):261. doi: 10.1186/s13063-015-1151-x.

  PMID: 27220675 DERIVED

MeSH Terms

Interventions

Magnesium Sulfate; Sodium Chloride

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Officials

• Suzanne Schuh, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: September 2, 2011
• First Posted: September 7, 2011
• Study Start: September 26, 2011
• Primary Completion: November 19, 2019
• Study Completion: November 22, 2019
• Last Updated: April 2, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)