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Completed

NCT Number: NCT01856959

Lung Function Changes of Induced Asthma Children Treated With Inhaled MgSO4

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.

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Key information

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Chongqing, Chongqing Municipality, 400014, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulfate

Drug

2ml of 7.5% solution of isotonic magnesium heptahydrate, 150 mg

Magnesium Sulfate & albuterol

Drug

0.5ml of albuterol mixed with 2ml of isotonic magnesium sulfate,150mg+2.5mg

albuterol

Drug

0.5ml of albuterol mixed with 1.5cc of normal saline, 2.5 mg

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 20, 2013
Registry last updated
May 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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