Lung Function of Asthmatic Children by Nebulized MgSO4

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Drug: Magnesium Sulfate & albuterol; Drug: albuterol; Drug: magnesium

• Registration Number: NCT01799109
• Lead Sponsor: Chongqing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2012-01
• Study Completion: 2012-03
• Study First Submitted: 2012-11-23
• Study First Submitted QC: 2013-02-23
• Study First Posted: 2013-02-26
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-17
• Last Update Posted: 2013-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nebulization ms and albuterol	Magnesium Sulfate & albuterol	magnesium sulfate 150mg \& albuterol 2.5mg nebulized with 5-6L/min of oxygen and consisted about 5 min,which used only once
nebulized albuterol	albuterol	albuterol 2.5mg nebulized with 5-6L/min of oxygen and consisted about 5 min,which used only once
nebulized ms	magnesium	magnesium sulfate 150mg nebulized with 5-6L/min of oxygen and consisted about 5 min,which used only once

Primary Outcome Measures

Name	Time	Method
changes of lung function	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.

Secondary Outcome Measures

Name	Time	Method
Nebulized magnesium sulfate alone effectively improve lung function	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
the number of participants with adverse events as a measure of safety and tolerability	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.

Trial Locations

Locations (1)

Center of Respiratory Disorders,Children's Hospital,Chongqing medical university; 🇨🇳 Chongqing, Chongqing, China