Nebulized Magnesium Sulfate as an Adjunct to Standard Therapy in Asthma Exacerbation

NCT02584738 | Unknown Phase 4

• 1 other identifier: HGNAE-03
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effectiveness of nebulized magnesium sulfate in patient with moderate to severe asthma exacerbation in pediatric emergency

Conditions

Asthma

Keywords

Asthma; Exacerbation; Nebulization; Magnesium; Pediatric

Outcome Measures

Primary Outcomes (6)

• Change from Baseline Preschool Respiratory Assessment Measure (PRAM)

  Scalene muscle contraction, Suprasternal retractions, Wheezing, Air entry and O2 saturation. The score will be considering from the addition per each primary measure.

  20, 40, 60, 120, 180 and 240 minutes after beginning treatment

• Change from Baseline Scalene muscle contraction

  Absent (0) or Present (2)

  20, 40, 60, 120, 180 and 240 minutes after beginning treatment

• Change from Baseline Suprasternal retractions

  Absent (0) or Present (2)

  20, 40, 60, 120, 180 and 240 minutes after beginning treatment

• Change from Baseline Wheezing

  Normal (0), Decreased at bases (1), Widespread decrease (2), or Absent/minimal (3)

  20, 40, 60, 120, 180 and 240 minutes after beginning treatment

• Change from Baseline Air entry

  Absent (0), Expiratory only (1), Inspiratory and expiratory (2) or Audible without (3) stethoscope/silent chest with minimal air entry

  20, 40, 60, 120, 180 and 240 minutes after beginning treatment

• Change from Baseline O2 saturation

  ≥95% (0), 92%-94% (1) or \<92% (2)

  20, 40, 60, 120, 180 and 240 minutes after beginning treatment

Secondary Outcomes (4)

• Rate of hospitalization

  4 hour

• Change from Baseline Heart rate

  20, 40, 60, 120, 180 and 240 minutes after beginning treatment

• Change from Baseline Respiratory rate

  20, 40, 60, 120, 180 and 240 minutes after beginning treatment

• Change from Baseline Blood pressure

  60 minutes after beginning treatment

Study Arms (2)

Nebulized Magnesium Sulfate

EXPERIMENTAL

Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic MgSO4. Intravenous methylprednisolone or oral prednisolone

Drug: Nebulized Magnesium Sulfate; Drug: Nebulized Salbutamol; Drug: Ipratropium bromide; Drug: Methylprednisolone or Prednisolone

Nebulized isotonic saline

PLACEBO COMPARATOR

Nebulized salbutamol and ipratropium bromide with 2.5 ml of isotonic saline. Intravenous methylprednisolone or oral prednisolone

Drug: Nebulized isotonic saline; Drug: Nebulized Salbutamol; Drug: Ipratropium bromide; Drug: Methylprednisolone or Prednisolone

Interventions

Nebulized Magnesium Sulfate DRUG

Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic MgSO4 (150 mg) per dose every 20 minutes during the first hour. will be continued with nebulized standard treatment every hour for 4 hours.

Also known as: MgSO4

Nebulized Magnesium Sulfate

Nebulized isotonic saline DRUG

Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic saline per dose every 20 minutes during the first hour. will be continued with nebulized standard treatment every hour for 4 hours.

Also known as: Standard treatment

Nebulized isotonic saline

Nebulized Salbutamol DRUG

Nebulized salbutamol 2.5mg (2-5 years) or 5 mg (≥6 years)

Nebulized Magnesium Sulfate; Nebulized isotonic saline

Ipratropium bromide DRUG

Nebulized ipratropium bromide 250 mcg

Nebulized Magnesium Sulfate; Nebulized isotonic saline

Methylprednisolone or Prednisolone DRUG

Begin with intravenous methylprednisolone or oral prednisolone 2 mg/kg/day for each treatment

Also known as: Corticosteroid therapy

Nebulized Magnesium Sulfate; Nebulized isotonic saline

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis of moderate or severe asthma exacerbations
• to 15 years old.
• Served in the pediatric emergency department of naval high specialty General Hospital from September to December 2015.
• Signing the consent by the parents.

You may not qualify if:

• Coexistence of lung disease.
• Severe kidney disease.
• Severe liver disease.
• Pregnancy.
• Known previous reaction to magnesium.
• Parents who have not signed the agreement.
• Patients without a clinical history of asthma.
• Clinical diagnosis of mild asthma attack.
• Previously included in the study.
• Presence of comorbidities that endanger the patient's life.
• The patient has clinical or gasometric criteria for advanced airway management.
• Life-threatening symptoms.

Sponsors & Collaborators

• Hospital General Naval de Alta Especialidad - Escuela Medico Naval: lead

Study Sites (1)

Hospital General Naval de Alta Especialidad

Mexico City, Mexico City, 04480, Mexico

RECRUITING

Related Publications (17)

• Birken CS, Parkin PC, Macarthur C. Asthma severity scores for preschoolers displayed weaknesses in reliability, validity, and responsiveness. J Clin Epidemiol. 2004 Nov;57(11):1177-81. doi: 10.1016/j.jclinepi.2004.02.016.

  PMID: 15567635 BACKGROUND

• Gorelick MH, Stevens MW, Schultz TR, Scribano PV. Performance of a novel clinical score, the Pediatric Asthma Severity Score (PASS), in the evaluation of acute asthma. Acad Emerg Med. 2004 Jan;11(1):10-8. doi: 10.1197/j.aem.2003.07.015.

  PMID: 14709423 BACKGROUND

• Rodrigo GJ, Plaza Moral V, Forns SB, Castro-Rodriguez JA, de Diego Damia A, Cortes SL, Moreno CM, Nannini LJ, Neffen H, Salas J; SEPAR; ALAT. [ALERTA 2 guidelines. Latin America and Spain: recommendations for the prevention and treatment of asmatic exacerbations. Spanish Pulmonology and Thoracic Surgery Society (SEPAR). Asthma Department of the Latinamerican Thoracic Association (ALAT)]. Arch Bronconeumol. 2010 Oct;46 Suppl 7:2-20. doi: 10.1016/S0300-2896(10)70041-7. No abstract available. Spanish.

  PMID: 21320808 BACKGROUND

• Gourgoulianis KI, Chatziparasidis G, Chatziefthimiou A, Molyvdas PA. Magnesium as a relaxing factor of airway smooth muscles. J Aerosol Med. 2001 Fall;14(3):301-7. doi: 10.1089/089426801316970259.

  PMID: 11693841 BACKGROUND

• Dominguez LJ, Barbagallo M, Di Lorenzo G, Drago A, Scola S, Morici G, Caruso C. Bronchial reactivity and intracellular magnesium: a possible mechanism for the bronchodilating effects of magnesium in asthma. Clin Sci (Lond). 1998 Aug;95(2):137-42.

  PMID: 9680494 BACKGROUND

• Cairns CB, Kraft M. Magnesium attenuates the neutrophil respiratory burst in adult asthmatic patients. Acad Emerg Med. 1996 Dec;3(12):1093-7. doi: 10.1111/j.1553-2712.1996.tb03366.x.

  PMID: 8959161 BACKGROUND

• Mohammed S, Goodacre S. Intravenous and nebulised magnesium sulphate for acute asthma: systematic review and meta-analysis. Emerg Med J. 2007 Dec;24(12):823-30. doi: 10.1136/emj.2007.052050.

  PMID: 18029512 BACKGROUND

• Shan Z, Rong Y, Yang W, Wang D, Yao P, Xie J, Liu L. Intravenous and nebulized magnesium sulfate for treating acute asthma in adults and children: a systematic review and meta-analysis. Respir Med. 2013 Mar;107(3):321-30. doi: 10.1016/j.rmed.2012.12.001. Epub 2013 Jan 3.

  PMID: 23290189 BACKGROUND

• Powell C, Dwan K, Milan SJ, Beasley R, Hughes R, Knopp-Sihota JA, Rowe BH. Inhaled magnesium sulfate in the treatment of acute asthma. Cochrane Database Syst Rev. 2012 Dec 12;12:CD003898. doi: 10.1002/14651858.CD003898.pub5.

  PMID: 23235599 BACKGROUND

• Goodacre S, Cohen J, Bradburn M, Gray A, Benger J, Coats T; 3Mg Research Team. Intravenous or nebulised magnesium sulphate versus standard therapy for severe acute asthma (3Mg trial): a double-blind, randomised controlled trial. Lancet Respir Med. 2013 Jun;1(4):293-300. doi: 10.1016/S2213-2600(13)70070-5. Epub 2013 May 17.

  PMID: 24429154 BACKGROUND

• Powell CV, Kolamunnage-Dona R, Lowe J, Boland A, Petrou S, Doull I, Hood K, Williamson PR; MAGNETIC study group. MAGNEsium Trial In Children (MAGNETIC): a randomised, placebo-controlled trial and economic evaluation of nebulised magnesium sulphate in acute severe asthma in children. Health Technol Assess. 2013 Oct;17(45):v-vi, 1-216. doi: 10.3310/hta17450.

  PMID: 24144222 BACKGROUND

• Alansari K, Ahmed W, Davidson BL, Alamri M, Zakaria I, Alrifaai M. Nebulized magnesium for moderate and severe pediatric asthma: A randomized trial. Pediatr Pulmonol. 2015 Dec;50(12):1191-9. doi: 10.1002/ppul.23158. Epub 2015 Feb 4.

  PMID: 25652104 BACKGROUND

• Rowe BH. Intravenous and inhaled MgSO4 for acute asthma. Lancet Respir Med. 2013 Jun;1(4):276-7. doi: 10.1016/S2213-2600(13)70097-3. Epub 2013 May 17. No abstract available.

  PMID: 24429139 BACKGROUND

• Petrou S, Boland A, Khan K, Powell C, Kolamunnage-Dona R, Lowe J, Doull I, Hood K, Williamson P. Economic evaluation of nebulized magnesium sulphate in acute severe asthma in children. Int J Technol Assess Health Care. 2014 Oct;30(4):354-60. doi: 10.1017/S0266462314000440. Epub 2014 Nov 14.

  PMID: 25394502 BACKGROUND

• Wang H, Xiong Y, Gong C, Yin L, Yan L, Yuan X, Liu S, Shi T, Dai J. Effect of inhaled magnesium sulfate on bronchial hyperresponsiveness. Indian J Pediatr. 2015 Apr;82(4):321-7. doi: 10.1007/s12098-014-1476-6. Epub 2014 Jun 12.

  PMID: 24916134 BACKGROUND

• Smith SR, Baty JD, Hodge D 3rd. Validation of the pulmonary score: an asthma severity score for children. Acad Emerg Med. 2002 Feb;9(2):99-104. doi: 10.1111/j.1553-2712.2002.tb00223.x.

  PMID: 11825832 RESULT

• Chalut DS, Ducharme FM, Davis GM. The Preschool Respiratory Assessment Measure (PRAM): a responsive index of acute asthma severity. J Pediatr. 2000 Dec;137(6):762-8. doi: 10.1067/mpd.2000.110121.

  PMID: 11113831 RESULT

Related Links

• Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention (Updated 2015).

MeSH Terms

Conditions

Asthma

Interventions

Ipratropium; Methylprednisolone; Prednisolone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jesús Abisai Uicab Saucedo, Pediatrician

  Secretaria de Marina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesús Abisai Uicab Saucedo, Pediatrician

CONTACT

(52)5550371200; abisaipec@msn.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 23, 2015
• Study Start: September 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2018
• Last Updated: December 2, 2015

Record last verified: 2015-10

Locations

ME (1)