Lung Function of Asthmatic Children by Nebulized MgSO4

May 17, 2013 updated by: Dai Jihong, Chongqing Medical University

Lung Function Changes of Mild to Moderate Asthmatic Children Treated by Nebulized MgSO4

Asthma is a common chronic respiratory illness which results in frequent wheezing, cough,reduced quality of life. Standard treatment for asthma attack includes oxygen therapy, β2-agonists (e.g. albuterol) and inhaled anticholinergics and corticosteroids. Although inhaled short-acting β2-agonists (SAB) is the initial choice to control acute asthma exacerbation, there are still some asthmatic children unresponsive to this management. The Global Initiative in National Asthma (GINA) does not recommend intravenous magnesium sulfate (MgSO4) for routine use in asthma exacerbation especially in young children. But intravenous MgSO4 can reduce hospital admission rates in certain patients due to several effects e.g relaxation of smooth muscle,blocking acetylcholine. In addition,adding MgSO4 to nebulized SAB provides greater benefit in severe asthma exacerbation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400014
        • Center of Respiratory Disorders,Children's Hospital,Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • asthmatic children with controlled clinical manifestation

Exclusion Criteria:

  • fever
  • history of chronic disease like bronchopulmonary dysplasia or cystic fibrosis
  • allergic to acetylcholine, albuterol or magnesium
  • use any bronchodilator agents before the Clinic day

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nebulization ms and albuterol
magnesium sulfate 150mg & albuterol 2.5mg nebulized with 5-6L/min of oxygen and consisted about 5 min,which used only once
Drug: Magnesium Sulfate & albuterol
Active Comparator: nebulized albuterol
albuterol 2.5mg nebulized with 5-6L/min of oxygen and consisted about 5 min,which used only once
Drug: albuterol
Experimental: nebulized ms
magnesium sulfate 150mg nebulized with 5-6L/min of oxygen and consisted about 5 min,which used only once
Drug: magnesium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes of lung function
Time Frame: 10minutes and 20minutes post-dose
to observe changes of Forced expiratory volume in one second and peak expiratory flow in controlled asthmatic children after respectively nebulized MgSO4、albuterol and combination of MgSO4 and albuterol in lung function test.
10minutes and 20minutes post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nebulized magnesium sulfate alone effectively improve lung function
Time Frame: 10minutes and 20minutes post-dose
After Ach challenge,FEV1 and PEF decreased in all three groups.But only in albuterol and magnesium group,they presented statistically significant while not in combination therapy group.After each intervention, FEV1 and PEF increased.But there was only statistically significant in FEV1 of magnesium and PEF of albuterol at 10 minutes and these two treatment at 20 minutes
10minutes and 20minutes post-dose
the number of participants with adverse events as a measure of safety and tolerability
Time Frame: 20minutes
to observe if anyone appear side effects such as nausea, vomiting, hypotension et al in patients who participating in our experiment. we did not found adverse reaction or other side effect in the study.
20minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing Medical University

Investigators

  • Study Director: Jihong Dai, professor, Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

November 23, 2012

First Submitted That Met QC Criteria

February 23, 2013

First Posted (Estimate)

February 26, 2013

Study Record Updates

Last Update Posted (Estimate)

May 21, 2013

Last Update Submitted That Met QC Criteria

May 17, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-2012CQ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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