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

Phase 4

Completed

• Conditions: Bronchial Asthma

• Registration Number: NCT00327028
• Lead Sponsor: Centre of Chinese Medicine, Georgia

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2005-09
• Study Completion: 2005-12
• Study First Submitted: 2006-05-15
• Study First Submitted QC: 2006-05-15
• Study First Posted: 2006-05-17
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-18
• Last Update Posted: 2009-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
At 3 months of treatment
Change from baseline of the PEFR and FEV1
Number of patients without asthma symptoms

Secondary Outcome Measures

Name	Time	Method
At 3 months of treatment
FEV1 before and after salbutamol inhalation
The daily (daytime and night-time) symptoms scores
Use of other antiasthmatic medication