Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00366067
Status:
COMPLETED
Last Update Posted:
2009-02-19
First Post:
2006-08-17
Brief Title:
Study of Efficacy of Phenytoin in Therapy of Children With Bronchial Asthma
Sponsor:
Centre of Chinese Medicine Georgia
Organization:
Centre of Chinese Medicine Georgia
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:
None
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?:
None