NCT00153270

Study of Efficacy of Sodium Valproate in Therapy of Bronchial Asthma

Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Sodium Valproate Efficacy in Asthma Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 46 (planned)
• Sponsor: Centre of Chinese Medicine, Georgia · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether antiepileptic drug sodium valproate is effective in the treatment of chronic asthma.

Detailed description

Effective therapy of asthma still remains quite serious problem. According GINA definition, asthma is an inflammatory disorder. Consequently, modern pharmacotherapy of asthma provides wide use of anti-inflammatory drugs. But asthma also is a paroxysmal disorder: many specialists and even some guidelines underline paroxysmal clinical picture of asthma. Besides this, according to some authors, neurogenic inflammation may play important role in asthma mechanism. But some other neurogenic inflammatory paroxysmal disorders exist, and they are migraine and trigeminal neuralgia. Some antiepileptic drugs, like carbamazepine and valproate, are very effective in therapy of migraine and trigeminal neuralgia - more than in 80% of cases. If bronchial asthma also is paroxysmal inflammatory disease, like migraine and trigeminal neuralgia, it is possible that some antiepileptic drugs also are very effective in asthma therapy. We performed a double-blind, placebo-controlled 3-month trial for evaluation of sodium valproate efficacy in therapy of bronchial asthma. Sodium Valproate is antiepileptic drug of new generation, initially produced by Sanofi Pharma. Comparison: Patients received investigational drug in addition to their usual routine antiasthmatic treatment, compared to patients received placebo in addition to their usual routine antiasthmatic treatment.

Conditions

• Bronchial Asthma

Interventions

Type	Name	Description
DRUG	Sodium Valproate

Timeline

• Start date: 2000-09-01
• Completion: 2001-04-01
• First posted: 2005-09-12
• Last updated: 2009-02-19