Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-25 @ 6:44 PM
Study NCT ID:
NCT00366067
Status:
COMPLETED
Last Update Posted:
2009-02-19
First Post:
2006-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Efficacy of Phenytoin in Therapy of Children With Bronchial Asthma
Sponsor:
Centre of Chinese Medicine, Georgia
Organization:
Study Overview
Official Title:
Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Phenytoin Efficacy in Children for Therapy of Bronchial Asthma
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to determine whether antiepileptic drug phenytoin is effective in the treatment of chronic asthma in children.
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. 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: