Lung Function of Asthmatic Children by Nebulized MgSO4

• ClinicalTrials.gov Identifier: NCT01799109
• Recruitment Status: Completed
• First Posted: February 26, 2013
• Last Update Posted: May 21, 2013
• Sponsor: Chongqing Medical University
• Information provided by (Responsible Party): Dai Jihong, Chongqing Medical University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Asthma	Drug: Magnesium Sulfate & albuterol; Drug: albuterol; Drug: magnesium	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Lung Function Changes of Mild to Moderate Asthmatic Children Treated by Nebulized MgSO4
• Study Start Date: November 2011
• Actual Primary Completion Date: January 2012
• Actual Study Completion Date: March 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 4 Years to 10 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

China, Chongqing

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

Chongqing, Chongqing, China, 400014

Sponsors and Collaborators

Chongqing Medical University

Investigators

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

More Information

• Responsible Party: Dai Jihong, professor, Chongqing Medical University
• ClinicalTrials.gov Identifier: NCT01799109
• Other Study ID Numbers: MS-2012CQ
• First Posted: February 26, 2013
• Last Update Posted: May 21, 2013
• Last Verified: May 2013

Keywords provided by Dai Jihong, Chongqing Medical University:

magnesium sulfate; nebulization; lung function

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Magnesium Sulfate; Albuterol; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Tocolytic Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Analgesics; Sensory System Agents; Anesthetics; Central Nervous System Depressants; Anti-Arrhythmia Agents