Bronchial Asthma Clinical Trial
Official title:
Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Sodium Valproate Efficacy in Asthma Therapy
The purpose of this study is to determine whether antiepileptic drug sodium valproate is effective in the treatment of chronic asthma.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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