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临床试验/NCT00327028
NCT00327028已完成4 期

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

Centre of Chinese Medicine, Georgia0 个研究点目标入组 61 人开始时间: 2005年9月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
61
主要终点
Change from baseline of the PEFR and FEV1

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change from baseline of the PEFR and FEV1

Number of patients without asthma symptoms

At 3 months of treatment

次要结局

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

研究者

发起方
Centre of Chinese Medicine, Georgia
申办方类型
Other

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