Study of Efficacy of Phenytoin in Therapy of Children With Bronchial Asthma
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|ClinicalTrials.gov Identifier: NCT00366067|
Recruitment Status : Completed
First Posted : August 18, 2006
Last Update Posted : February 19, 2009
|Condition or disease||Intervention/treatment||Phase|
|Bronchial Asthma||Drug: Phenytoin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Phenytoin Efficacy in Children for Therapy of Bronchial Asthma|
|Study Start Date :||August 2006|
|Actual Study Completion Date :||February 2007|
- At 3 months of treatment: Change from baseline of the FEV1 and PEFR (also %predicted); Number of patients without asthma symptoms
- At 3 months of treatment: Difference in PEF pm-am (in %); The daily (daytime and night-time) symptoms scores; % of symptom free days during the treatment period; Use of other antiasthmatic medication
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00366067
|"Rea" Rehabilitation Centre|
|Tbilisi, Georgia, 0160|
|Principal Investigator:||Merab Lomia, MD, PhD||"Rea" Rehabilitation Centre|
|Principal Investigator:||Tamuna Tchelidze||CRO Evidence|
|Principal Investigator:||Nana Zhorzholadze, MD||"Rea" Rehabilitation Centre|
|Study Director:||Manana Pruidze||Centre of Chinese Medicine|