Study of Efficacy of Phenytoin in Therapy of Patients With Bronchial Asthma

Study Overview
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Brief Summary
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The purpose of this study was evaluation the efficacy of antiepileptic drug phenytoin (diphenine) in the treatment of bronchial asthma.

Detailed Description
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Effective therapy of asthma still remains quite serious problem. According current opinion of leading specialists, asthma is an inflammatory disorder. But asthma also is a paroxysmal disorder: many specialists underline paroxysmal clinical picture of asthma. According to some authors, neurogenic inflammation may play important role in asthma mechanism. But migraine and trigeminal neuralgia are also neurogenic inflammatory paroxysmal diseases, and some antiepileptic drugs, like diphenine and valproates, are very effective in therapy of these diseases - more than in 80% of cases. If bronchial asthma also is paroxysmal inflammatory disease, we can suppose a possibility that some antiepileptic drugs also may show high efficacy in asthma therapy. Taken in consideration this hypothesis, we performed a double-blind, placebo-controlled 3-month trial for evaluation of phenytoin (diphenine) efficacy in treatment of patients with bronchial asthma.

Official Title
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Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Phenytoin Efficacy in Bronchial Asthma Therapy

Conditions
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Bronchial Asthma

Intervention / Treatment
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* Drug: Diphenine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Out patients Bronchial asthma has been known at least for 1 year Absence of long-term remissions of asthma (lasting more than 1 month) Poorly controlled asthma, due to various reasons Non-smokers Exclusion Criteria: Presence of concomitant acute or chronic severe diseases Abnormal baseline haematology, blood chemistry or urinalysis Allergy or adverse reactions to investigational drug Age younger than 18 years old Long-term history of smoking Pregnancy or lactating

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Diphenine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At 3 months of treatment |  |  | 
| Change from baseline of the PEFR and FEV1 |  |  | 
| Number of patients without asthma symptoms |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At 3 months of treatment |  |  | 
| FEV1 before and after salbutamol inhalation |  |  | 
| The daily (daytime and night-time) symptoms scores |  |  | 
| Use of other antiasthmatic medication |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchial asthma, Phenytoin, Diphenine, Antiepileptic drugs, Efficacy