Lung Function of Asthmatic Children by Nebulized MgSO4

Study Overview
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Brief Summary
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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.

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

Conditions
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Asthma

Intervention / Treatment
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* Drug: Magnesium Sulfate & albuterol
* Drug: albuterol
* Drug: magnesium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of lung function | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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magnesium sulfate, nebulization, lung function