Randomized, Placebo Controlled, Double Blind Study of Carbamazepine in Treatment of Bronchial Asthma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 主要终点
- At 3 months of treatment: Change from baseline of the PEFR (also %predicted); Number of patients without asthma symptoms
研究概览
简要总结
The purpose of this study was evaluation the efficacy of antiepileptic drug carbamazepine in the treatment of mild-to-severe 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 carbamazepine 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 carbamazepine efficacy in treatment of patients with mild-to-severe bronchial asthma.
Comparison: Patients received investigational drug in addition to their usual routine antiasthmatic treatment, compared to patients received placebo in addition to their usual routine antiasthmatic treatment.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 16 years old
- •Long-term history of smoking
- •Pregnancy or lactating
结局指标
主要结局
At 3 months of treatment: Change from baseline of the PEFR (also %predicted); Number of patients without asthma symptoms
次要结局
- At 3 months of treatment: PEFR before and after salbutamol inhalation;
- Difference in PEFR pm-am (in %); The daily (daytime and night-time) symptoms scores; Use of other antiasthmatic medication