Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lung Function of Asthmatic Children by Nebulized MgSO4

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01799109
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : May 21, 2013
Sponsor:
Information provided by (Responsible Party):
Dai Jihong, 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.

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

Layout table for study information
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


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



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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799109


Locations
Layout table for location information
China, Chongqing
Center of Respiratory Disorders,Children's Hospital,Chongqing medical university
Chongqing, Chongqing, China, 400014
Sponsors and Collaborators
Chongqing Medical University
Investigators
Layout table for investigator information
Study Director: Jihong Dai, professor Chongqing Medical University

Layout table for additonal information
Responsible Party: Dai Jihong, professor, Chongqing Medical University
ClinicalTrials.gov Identifier: NCT01799109     History of Changes
Other Study ID Numbers: MS-2012CQ
First Posted: February 26, 2013    Key Record Dates
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:
Layout table for 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