Study of Efficacy of Oxcarbazepine in Therapy of Bronchial Asthma

Study Overview
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Brief Summary
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The purpose of this study is to determine whether antiepileptic drug oxcarbazepine is effective in the treatment of chronic asthma.

Detailed Description
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Effective therapy of asthma still remains quite serious problem. According GINA definition, asthma is an inflammatory disorder. Consequently, modern pharmacotherapy of asthma provides wide use of anti-inflammatory drugs. But asthma also is a paroxysmal disorder: many specialists and even some guidelines underline paroxysmal clinical picture of asthma. Besides this, according to some authors, neurogenic inflammation may play important role in asthma mechanism. But some other neurogenic inflammatory paroxysmal disorders exist, and they are migraine and trigeminal neuralgia. Some antiepileptic drugs, like carbamazepine and valproate, are very effective in therapy of migraine and trigeminal neuralgia - more than in 80% of cases. If bronchial asthma also is paroxysmal inflammatory disease, like migraine and trigeminal neuralgia, it is possible that some antiepileptic drugs also are very effective in asthma therapy. We performed a double-blind, placebo-controlled 3-month trial for evaluation of oxcarbazepine efficacy in therapy of bronchial asthma. Oxcarbazepine is antiepileptic drug of new generation, produced by Novartis, and it is more effective and safe derivative of well-known antiepileptic drug carbamazepine. 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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Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Oxcarbazepine Efficacy in Asthma Therapy

Conditions
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Bronchial Asthma

Intervention / Treatment
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* Drug: Oxcarbazepine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 severe diseases Allergy or adverse reactions to carbamazepine or oxcarbazepine Abnormal baseline haematology, blood chemistry or urinalysis Current use of long-acting beta-agonists Age younger than 16 years old Long-term history of smoking Pregnancy or lactating

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 75 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: Oxcarbazepine|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 FEV1 and PEFR (also %predicted); Number of patients without asthma symptoms |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At 3 months of treatment: FEV1 before and after salbutamol inhalation; Difference in PEF pm-am (in %); The daily (daytime and night-time) symptoms scores; % of symptom free days during the treatment period; 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, Oxcarbazepine, Antiepileptic drug, Efficacy