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OpenTrials
Completed

NCT Number: NCT01799109

Lung Function of Asthmatic Children 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.

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Key information

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of Respiratory Disorders,Children's Hospital,Chongqing medical university

Chongqing, Chongqing Municipality, 400014, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium Sulfate & albuterol

Drug

albuterol

Drug

Magnesium

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 26, 2013
Registry last updated
May 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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