Antiepileptic Drug Carbamazepine in Treatment of Bronchial Asthma

Study Overview
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Brief Summary
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The purpose of this study was evaluation the efficacy of antiepileptic drug carbamazepine in the treatment of mild-to-severe bronchial asthma.

Detailed Description
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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.

Official Title
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Randomized, Placebo Controlled, Double Blind Study of Carbamazepine in Treatment of Bronchial Asthma

Conditions
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Bronchial Asthma

Intervention / Treatment
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* Drug: Carbamazepine


Participation Criteria
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Eligibility Criteria
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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 16 years old Long-term history of smoking Pregnancy or lactating

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Carbamazepine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At 3 months of treatment: Change from baseline of the PEFR (also %predicted); Number of patients without asthma symptoms |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchial asthma, Carbamazepine, Efficacy