<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04497766</url>
  </required_header>
  <id_info>
    <org_study_id>137/RC/KEMU</org_study_id>
    <nct_id>NCT04497766</nct_id>
  </id_info>
  <brief_title>Comparasion of Efficacy of Nebulized With Intravenous Magnesium Sulphate in Children With Asthma</brief_title>
  <official_title>Comparasion of Efficacy of Nebulized Magnesium Sulphate With Intravenous Magnesium Sulphate in Children With Acute Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saima Khatoon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>King Edward Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>King Edward Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of study is to assess the effectiveness of nebulized magnesium sulphate in&#xD;
      children presenting with acute asthma.Study perfoma consists of demographic&#xD;
      variables,exclusion criteria and pediatric asthma score that includes respiratory rate,SPO2&#xD;
      at room air(requirement of oxygen),auscultatory findings in chest,dysnea and retractions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After getting informed consent from guardian,148 patients of acute moderate ro severe asthma&#xD;
      with pediatric asthma score 8-15 will be randomly classified into 2 groups and one group will&#xD;
      receive nebulization with magnesium sulphate and other will receive intravenous magnesium&#xD;
      sulphate and effectiveness will be compared by 4 point reduction in PAS from baseline in&#xD;
      either groups after 6 hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of nebulized magnesium sulphate with intravenous magnesium sulphate in children with acute asthma will be assessed by a drop in PAS score, as assessed at 6 hours of intervention.</measure>
    <time_frame>6 hours</time_frame>
    <description>The intervention will be considered effective if there is a drop of at least 4 points in PAS score at hour-6 of intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>duration of ICU stay</measure>
    <time_frame>72 hours/3 days</time_frame>
    <description>this will be measured in hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of hospital stay</measure>
    <time_frame>120 hours/5 days</time_frame>
    <description>this will be measured in hours</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>Asthma in Children</condition>
  <arm_group>
    <arm_group_label>Nebulized magnesium sulphate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100mg of mgso4 in 20ml of normal saline via ultrasonic nebulizer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravenous magnesium sulphate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Magnesium sulphate according to weight will be given intravenously.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nebulized Magnesium sulfate</intervention_name>
    <description>MgSO4 100mg in 20 ml normal saline will be given via ultrasonic nebulizer over 10 minutes,and PAS score will be assessed at 30,60,120,240,360 minutes</description>
    <arm_group_label>Nebulized magnesium sulphate</arm_group_label>
    <other_name>Nebulized MgSO4</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous magnesium sulphate</intervention_name>
    <description>pts age 2 to 12 years will receive intravenous magnesium sulphate 50 mg/kg over half hour</description>
    <arm_group_label>Intravenous magnesium sulphate</arm_group_label>
    <other_name>IV MgSO4</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with age 2 to 12 years with acute moderate to severe exacerbation of asthma&#xD;
             as per operational definition children who are unrespoinsive to standard treatment of&#xD;
             asthma at 60 minutes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  those with history of chronic lung disease and abnormal renal function&#xD;
             contraindication for MgSO4 due to hepatic or renal disease allergy to MgSo4 children&#xD;
             who has other comorbid illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Muhammad-Haroon Hamid, MBBS,FCPS,FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>chairman /Head of department of pediatrics unit1 K.E medical university/mayo hospital l</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>King edward medical university/mayo hospital lahore</name>
      <address>
        <city>Lahore</city>
        <state>Punjab</state>
        <zip>56000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <link>
    <url>http://pubmed.ncbi.nlm.nih.gov/24429155/</url>
    <description>Powell C, Dona RK, Lowe, J, Boland A, Petrou S, Doull I, et al. Magnesium sulphate in acute sever asthma in children (MAGNETIC): a randomized, placebo-controlled trial. The Lancet Respiratory Medicine. 2013;1(4):301-8.</description>
  </link>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/25024668</url>
    <description>Kokotajlo S, Degnan L, Meyers R, Siu A, Robinson C. Use of intravenous magnesium sulfate for the treatment of an acute asthma exacerbation in pediatric patients.J Pediatr Pharmacol Ther. 2014;19(2) :91-7.</description>
  </link>
  <link>
    <url>http://pubmed.ncbi.nlm.nih.gov/24429154/</url>
    <description>Goodacre S, Cohen J, 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;1(4</description>
  </link>
  <link>
    <url>http://pubmed.ncbi.nlm.nih.gov/25164315/</url>
    <description>Singhi S, Grover S, Bansal A, Chopra K. Randomised comparison of intravenous magnesium sulphate, terbutaline and aminophylline for children with acute severe asthma. Acta Peadiatrica. 2014;103(12):1301-6</description>
  </link>
  <link>
    <url>http://pubmed.ncbi.nlm.nih.gov/23290189/</url>
    <description>Shan Z, Rong Y, Yang W, Wang D, Yao P, Xie J,et al. Intravenous and nebulized magnesium sulfate for treating acute asthma in adults and children: a systematic review and meta-analysis. Respiratory medicine. 2013;107(3):321-30.</description>
  </link>
  <link>
    <url>http://pubmed.ncbi.nlm.nih.gov/25652104/</url>
    <description>Alansari K, Ahmed W, Davidson B, Alamri M, Zakaria I, Alrifaari M. Nebulized magnesium for moderate and severe pediatric asthma: A randomized tria.Pediatr Pumonol 2015;50(12):1191-9.</description>
  </link>
  <link>
    <url>http://pubmed.ncbi.nlm.nih.gov/24345031/</url>
    <description>Albuali WH. The Use of Intravenous and inhaled magnesium sulphate in management of children with bronchial asthma. J Matern Fetal Neonatal.2014;27(17):1809-15.</description>
  </link>
  <link>
    <url>http://pubmed.ncbi.nlm.nih.gov/27996280/</url>
    <description>aengsuwan T, Watanatham S. A comparative pilot study of the efficacy and safety of nebulized magnesium sulfate and intravenous magnesium sulfate in children with severe acute asthma. Asian Pac/allergy immunol. 2016; 35(2):108-</description>
  </link>
  <reference>
    <citation>Powell C, Kolamunnage-Dona R, Lowe J, Boland A, Petrou S, Doull I, Hood K, Williamson P; MAGNETIC study group. Magnesium sulphate in acute severe asthma in children (MAGNETIC): a randomised, placebo-controlled trial. Lancet Respir Med. 2013 Jun;1(4):301-8. doi: 10.1016/S2213-2600(13)70037-7. Epub 2013 Apr 22. Erratum In: Lancet Respir Med. 2013 Jun;1(4):285.</citation>
    <PMID>24429155</PMID>
  </reference>
  <reference>
    <citation>Kokotajlo S, Degnan L, Meyers R, Siu A, Robinson C. Use of intravenous magnesium sulfate for the treatment of an acute asthma exacerbation in pediatric patients. J Pediatr Pharmacol Ther. 2014 Apr;19(2):91-7. doi: 10.5863/1551-6776-19.2.91.</citation>
    <PMID>25024668</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24429154</PMID>
  </reference>
  <reference>
    <citation>Singhi S, Grover S, Bansal A, Chopra K. Randomised comparison of intravenous magnesium sulphate, terbutaline and aminophylline for children with acute severe asthma. Acta Paediatr. 2014 Dec;103(12):1301-6. doi: 10.1111/apa.12780. Epub 2014 Oct 2.</citation>
    <PMID>25164315</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23290189</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25652104</PMID>
  </reference>
  <reference>
    <citation>Albuali WH. The use of intravenous and inhaled magnesium sulphate in management of children with bronchial asthma. J Matern Fetal Neonatal Med. 2014 Nov;27(17):1809-15. doi: 10.3109/14767058.2013.876620. Epub 2014 Jan 30.</citation>
    <PMID>24345031</PMID>
  </reference>
  <reference>
    <citation>Daengsuwan T, Watanatham S. A comparative pilot study of the efficacy and safety of nebulized magnesium sulfate and intravenous magnesium sulfate in children with severe acute asthma. Asian Pac J Allergy Immunol. 2017 Jun;35(2):108-112. doi: 10.12932/AP0780.</citation>
    <PMID>27996280</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>February 19, 2021</last_update_submitted>
  <last_update_submitted_qc>February 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>King Edward Medical University</investigator_affiliation>
    <investigator_full_name>Saima Khatoon</investigator_full_name>
    <investigator_title>Post Graduate Resident in Pediatrics (MD Paeds)</investigator_title>
  </responsible_party>
  <keyword>asthma in children</keyword>
  <keyword>intravenous magnesium sulphate</keyword>
  <keyword>nebulized magnesium sulphate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Magnesium Sulfate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will be shared after publication on a reasonable request.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04497766
org study id: 137/RC/KEMU
nct id: NCT04497766
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of study is to assess the effectiveness of nebulized magnesium sulphate in
      children presenting with acute asthma.Study perfoma consists of demographic
      variables,exclusion criteria and pediatric asthma score that includes respiratory rate,SPO2
      at room air(requirement of oxygen),auscultatory findings in chest,dysnea and retractions.
After getting informed consent from guardian,148 patients of acute moderate ro severe asthma
      with pediatric asthma score 8-15 will be randomly classified into 2 groups and one group will
      receive nebulization with magnesium sulphate and other will receive intravenous magnesium
      sulphate and effectiveness will be compared by 4 point reduction in PAS from baseline in
      either groups after 6 hours.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Efficacy of nebulized magnesium sulphate with intravenous magnesium sulphate in children with acute asthma will be assessed by a drop in PAS score, as assessed at 6 hours of intervention.
time frame: 6 hours
description: The intervention will be considered effective if there is a drop of at least 4 points in PAS score at hour-6 of intervention.
measure: duration of ICU stay
time frame: 72 hours/3 days
description: this will be measured in hours
measure: duration of hospital stay
time frame: 120 hours/5 days
description: this will be measured in hours
arm group label: Nebulized magnesium sulphate
arm group type: Experimental
description: 100mg of mgso4 in 20ml of normal saline via ultrasonic nebulizer
arm group label: Intravenous magnesium sulphate
arm group type: Experimental
description: Magnesium sulphate according to weight will be given intravenously.
intervention type: Drug
intervention name: Nebulized Magnesium sulfate
description: MgSO4 100mg in 20 ml normal saline will be given via ultrasonic nebulizer over 10 minutes,and PAS score will be assessed at 30,60,120,240,360 minutes
arm group label: Nebulized magnesium sulphate
other name: Nebulized MgSO4
intervention type: Drug
intervention name: Intravenous magnesium sulphate
description: pts age 2 to 12 years will receive intravenous magnesium sulphate 50 mg/kg over half hour
arm group label: Intravenous magnesium sulphate
other name: IV MgSO4
criteria: 
gender: All
minimum age: 2 Years
maximum age: 12 Years
healthy volunteers: No
last name: Muhammad-Haroon Hamid, MBBS,FCPS,FRCP
role: Principal Investigator
affiliation: chairman /Head of department of pediatrics unit1 K.E medical university/mayo hospital l
facility: 
country: Pakistan
url: http://pubmed.ncbi.nlm.nih.gov/24429155/
description: Powell C, Dona RK, Lowe, J, Boland A, Petrou S, Doull I, et al. Magnesium sulphate in acute sever asthma in children (MAGNETIC): a randomized, placebo-controlled trial. The Lancet Respiratory Medicine. 2013;1(4):301-8.
url: https://pubmed.ncbi.nlm.nih.gov/25024668
description: Kokotajlo S, Degnan L, Meyers R, Siu A, Robinson C. Use of intravenous magnesium sulfate for the treatment of an acute asthma exacerbation in pediatric patients.J Pediatr Pharmacol Ther. 2014;19(2) :91-7.
url: http://pubmed.ncbi.nlm.nih.gov/24429154/
description: Goodacre S, Cohen J, 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;1(4
url: http://pubmed.ncbi.nlm.nih.gov/25164315/
description: Singhi S, Grover S, Bansal A, Chopra K. Randomised comparison of intravenous magnesium sulphate, terbutaline and aminophylline for children with acute severe asthma. Acta Peadiatrica. 2014;103(12):1301-6
url: http://pubmed.ncbi.nlm.nih.gov/23290189/
description: Shan Z, Rong Y, Yang W, Wang D, Yao P, Xie J,et al. Intravenous and nebulized magnesium sulfate for treating acute asthma in adults and children: a systematic review and meta-analysis. Respiratory medicine. 2013;107(3):321-30.
url: http://pubmed.ncbi.nlm.nih.gov/25652104/
description: Alansari K, Ahmed W, Davidson B, Alamri M, Zakaria I, Alrifaari M. Nebulized magnesium for moderate and severe pediatric asthma: A randomized tria.Pediatr Pumonol 2015;50(12):1191-9.
url: http://pubmed.ncbi.nlm.nih.gov/24345031/
description: Albuali WH. The Use of Intravenous and inhaled magnesium sulphate in management of children with bronchial asthma. J Matern Fetal Neonatal.2014;27(17):1809-15.
url: http://pubmed.ncbi.nlm.nih.gov/27996280/
description: aengsuwan T, Watanatham S. A comparative pilot study of the efficacy and safety of nebulized magnesium sulfate and intravenous magnesium sulfate in children with severe acute asthma. Asian Pac/allergy immunol. 2016; 35(2):108-
citation: Powell C, Kolamunnage-Dona R, Lowe J, Boland A, Petrou S, Doull I, Hood K, Williamson P; MAGNETIC study group. Magnesium sulphate in acute severe asthma in children (MAGNETIC): a randomised, placebo-controlled trial. Lancet Respir Med. 2013 Jun;1(4):301-8. doi: 10.1016/S2213-2600(13)70037-7. Epub 2013 Apr 22. Erratum In: Lancet Respir Med. 2013 Jun;1(4):285.
PMID: 24429155
citation: Kokotajlo S, Degnan L, Meyers R, Siu A, Robinson C. Use of intravenous magnesium sulfate for the treatment of an acute asthma exacerbation in pediatric patients. J Pediatr Pharmacol Ther. 2014 Apr;19(2):91-7. doi: 10.5863/1551-6776-19.2.91.
PMID: 25024668
citation: 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
citation: Singhi S, Grover S, Bansal A, Chopra K. Randomised comparison of intravenous magnesium sulphate, terbutaline and aminophylline for children with acute severe asthma. Acta Paediatr. 2014 Dec;103(12):1301-6. doi: 10.1111/apa.12780. Epub 2014 Oct 2.
PMID: 25164315
citation: 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
citation: 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
citation: Albuali WH. The use of intravenous and inhaled magnesium sulphate in management of children with bronchial asthma. J Matern Fetal Neonatal Med. 2014 Nov;27(17):1809-15. doi: 10.3109/14767058.2013.876620. Epub 2014 Jan 30.
PMID: 24345031
citation: Daengsuwan T, Watanatham S. A comparative pilot study of the efficacy and safety of nebulized magnesium sulfate and intravenous magnesium sulfate in children with severe acute asthma. Asian Pac J Allergy Immunol. 2017 Jun;35(2):108-112. doi: 10.12932/AP0780.
PMID: 27996280
responsible party type: Sponsor-Investigator
investigator affiliation: King Edward Medical University
investigator full name: Saima Khatoon
investigator title: Post Graduate Resident in Pediatrics (MD Paeds)
mesh term: Asthma
mesh term: Magnesium Sulfate
sharing ipd: No
ipd description: Data will be shared after publication on a reasonable request.