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Lung Function Changes of Induced Asthma Children Treated With Inhaled MgSO4

Information source: Chongqing Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Magnesium Sulfate (Drug); magnesium sulfate & albuterol (Drug); Albuterol (Drug)

Phase: N/A

Status: Completed

Sponsored by: Chongqing Medical University

Official(s) and/or principal investigator(s):
Jihong Dai, M.D., Study Director, Affiliation: Chongqing Medical University

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: changes of lung function after interventions

Secondary outcome:

effectiveness of nebulized magnesium sulfate alone

the number of patients with adverse events as a measure of safety and tolerability

Eligibility

Minimum age: 4 Years. Maximum age: 16 Years. Gender(s): Both.

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

Locations and Contacts

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

Starting date: November 2011
Last updated: May 17, 2013

Page last updated: August 23, 2015

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