Lung Function Changes of Induced Asthma Children Treated With Inhaled MgSO4

May 17, 2013 updated by: Dai Jihong, Chongqing Medical University

Response of Asthmatic Children's Lung Function to Nebulized Magnesium Sulfate After Acetylcholine Provocation Test: a Clinical Trail

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400014
        • Center of Respiratory Disorders,Children's Hospital,Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 min and 20 min post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 min and 20 min post-dose
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.
20 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing Medical University

Investigators

  • Study Director: Jihong Dai, M.D., Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

May 14, 2013

First Submitted That Met QC Criteria

May 17, 2013

First Posted (ESTIMATE)

May 20, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 20, 2013

Last Update Submitted That Met QC Criteria

May 17, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-2013CQ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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