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

C

Centre of Chinese Medicine, Georgia

Status and phase

Completed
Phase 4

Conditions

Bronchial Asthma

Treatments

Drug: Diphenine

Study type

Interventional

Funder types

Other

Identifiers

NCT00327028
LTP-DP-0505-1205

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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