Study of Efficacy of Oxcarbazepine in Therapy of Bronchial Asthma

NCT ID: NCT00142025

Last Updated: 2009-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-09-30
• Study Completion Date: 2002-03-31

Brief Summary

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

Detailed Description

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.

Conditions

Bronchial Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Oxcarbazepine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rea Rehabilitation Centre, Georgia

OTHER

Sponsor Role: collaborator

Centre of Chinese Medicine, Georgia

OTHER

Sponsor Role: lead

Principal Investigators

Merab Lomia, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

"Rea" Rehabilitation Centre.

Manana Tchaia, MD

Role: STUDY_DIRECTOR

Centre of Chinese Medicine

Tamara Tchelidze, MD

Role: STUDY_CHAIR

CRO Evidence

Related Links

http://www.asthma.ge

Website of Neuroasthma Group

http://www.ncbi.nlm.nih.gov/pubmed/16597501?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum

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

Other Identifiers

LP-0501-OC-0302

Identifier Type: -

Identifier Source: org_study_id