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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00327028

Enrollment

Registered

2006-05-17

Start date

2005-09-30

Completion date

2005-12-31

Last updated

2009-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Asthma

Keywords

Bronchial asthma, Phenytoin, Diphenine, Antiepileptic drugs, Efficacy

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.

Interventions

DRUGDiphenine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
At 3 months of treatment	—
Change from baseline of the PEFR and FEV1	—
Number of patients without asthma symptoms	—

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026