Lung Function of Asthmatic Children by Nebulized MgSO4

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799109
• Other study ID #: MS-2012CQ
• Status: Completed
• Phase: N/A
• First received: November 23, 2012
• Last updated: May 17, 2013
• Start date: November 2011
• Est. completion date: March 2012

Study information

• Verified date: May 2013
• Source: Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 10 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Magnesium Sulfate & albuterol

• albuterol

• magnesium

Locations

Country	Name	City	State
China	Center of Respiratory Disorders,Children's Hospital,Chongqing medical university	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes