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Lung Function Changes of Induced Asthma Children Treated With Inhaled MgSO4

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ClinicalTrials.gov Identifier: NCT01856959
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : May 20, 2013
Sponsor:
Information provided by (Responsible Party):
Dai Jihong, Chongqing Medical University

Brief Summary:
As a non-selective bronchodilator, magnesium sulfate (MgSO4) is effective when administered intravenously in the treatment of the patients with acute severe asthma not responding to conventional therapy (oxygen, nebulized salbutamol, and corticosteroids), which can resulted in earlier improvement in clinical signs and symptoms of asthma and PEF. However, the use of intravenous MgSO4 administered is not common in clinical practice, because it's prone to have adverse effects and side effects such as nausea, vomiting, facial flushing, hypotension, decreased tendon reflexes and so on with this treatment. The aerosolised route offers the advantage of lower dosage, a shorter time of drug being delivered to the airway smooth muscle and lower incidence of side effects when compared to the intravenous route. At present, there are only a few studies about the effects of nebulized MgSO4 in the treatment of acute asthma in children, and the conclusions are controversial.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Response of Asthmatic Children's Lung Function to Nebulized Magnesium Sulfate After Acetylcholine Provocation Test: a Clinical Trail
Study Start Date : November 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : May 2013


Arm Intervention/treatment
Experimental: nebulized magnesium sulfate
nebulized magnesium sulfate 150mg and consisted about 5 min,which used only once
Drug: Magnesium Sulfate
2ml of 7.5% solution of isotonic magnesium heptahydrate, 150 mg

Experimental: nebulized magnesium sulfate & albuterol
nebulized magnesium sulfate 150mg & albuterol 2.5mg and consisted about 5 min,which used only once
Drug: magnesium sulfate & albuterol
0.5ml of albuterol mixed with 2ml of isotonic magnesium sulfate,150mg+2.5mg

Active Comparator: nebulized albuterol
nebulized albuterol 2.5mg and consisted about 5 min,which used only once
Drug: Albuterol
0.5ml of albuterol mixed with 1.5cc of normal saline, 2.5 mg




Primary Outcome Measures :
  1. changes of lung function after interventions [ Time Frame: 10 min and 20 min post-dose ]
    to observe the changes of the lung function indices(FEV1、PEF) at 10 min and 20 min after inhaling magnesium sulfate, albuterol, or combination of magnesium sulfate and albuterol respectively.


Secondary Outcome Measures :
  1. effectiveness of nebulized magnesium sulfate alone [ Time Frame: 10 min and 20 min post-dose ]
    to observe the changes of the lung function indices(FEV1、PEF) at 10 min and 20 min after inhaling magnesium sulfate alone,and compared it with the patients who was nebulized inhalation albuterol alone.

  2. the number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 20 min ]
    to observe if any patient appear side effects or adverse effects like nausea, vomiting, hypotension or the change of deep tendon reflexes et al.



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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • known cases of controlled bronchial asthma
  • ≧4 years of age
  • the result was positive after acetylcholine provocation test in follow-up visit

Exclusion Criteria:

  • had received corticosteroids (inhaled or systemic) or β2-agonists or theophyllines before the clinic day
  • had fever (axillary temperature>38.5℃)
  • history of chronic disease like bronchopulmonary dysplasia or cystic fibrosis
  • history of renal insufficiency and known allergy to acetylcholine, albuterol or magnesium

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): NCT01856959


Locations
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China, Chongqing
Center of Respiratory Disorders,Children's Hospital,Chongqing Medical University
Chongqing, Chongqing, China, 400014
Sponsors and Collaborators
Chongqing Medical University
Investigators
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Study Director: Jihong Dai, M.D. Chongqing Medical University

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Responsible Party: Dai Jihong, professor, Chongqing Medical University
ClinicalTrials.gov Identifier: NCT01856959     History of Changes
Other Study ID Numbers: MS-2013CQ
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: May 20, 2013
Last Verified: May 2013
Keywords provided by Dai Jihong, Chongqing Medical University:
magnesium sulfate
nebulized
lung function
Additional relevant MeSH terms:
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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