Bronchial Asthma Clinical Trial
Official title:
Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Phenytoin Efficacy in Children for Therapy of Bronchial Asthma
The purpose of this study was to determine whether antiepileptic drug phenytoin is effective in the treatment of chronic asthma in children.
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. It is known that some other neurogenic inflammatory paroxysmal disorders
exist, and they are migraine and trigeminal neuralgia. Antiepileptic drug phenytoin is very
effective in therapy of trigeminal neuralgia - more than in 70-80% of cases. Other
antiepileptic drugs, salts of valproic acid, are effective in the treatment of migraine. 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 perform a double-blind, placebo-controlled 3-month trial for evaluation of phenytoin
efficacy in therapy of bronchial asthma in children. Phenytoin is a well-known,
comparatively safe and effective antiepileptic drug with low cost. According our previous
data, phenytoin is effective drug for asthma therapy in adults.
Comparison: children will receive 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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