Official Title: “Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Oxcarbazepine Efficacy in Asthma Therapy”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Oxcarbazepine

Primary Measures

• At 3 months of treatment: Change from baseline of the FEV1 and PEFR (also %predicted); Number of patients without asthma symptoms

Secondary Measures

• 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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 17 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Centre of Chinese Medicine, Georgia

Overall Clinical Trial Officials and Contacts

Merab Lomia, MD, PhD Principal Investigator "Rea" Rehabilitation Centre.  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00142025

Study ID Number: LP-0501-OC-0302

ClinicalTrials.gov Identifier: NCT00142025

Health Authority: Georgia: Ministry of Health

Website of Neuroasthma Group

Bronchial asthma as neurogenic paroxysmal inflammatory disease: a randomized trial with carbamazepine