Study of Efficacy of Oxcarbazepine in Therapy of Bronchial Asthma

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Bronchial Asthma	Drug: Oxcarbazepine	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	55 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Oxcarbazepine Efficacy in Asthma Therapy
Study Start Date :	September 2001
Study Completion Date :	March 2002

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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

Eligibility Criteria

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Ages Eligible for Study:	17 Years to 75 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Centre of Chinese Medicine, Georgia

Rea Rehabilitation Centre, Georgia

Investigators

Principal Investigator:	Merab Lomia, MD, PhD	"Rea" Rehabilitation Centre.
Study Director:	Manana Tchaia, MD	Centre of Chinese Medicine
Study Chair:	Tamara Tchelidze, MD	CRO Evidence

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Website of Neuroasthma Group 

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

ClinicalTrials.gov Identifier:	NCT00142025 History of Changes
Other Study ID Numbers:	LP-0501-OC-0302
First Posted:	September 2, 2005
Last Update Posted:	February 19, 2009
Last Verified:	February 2009

Keywords provided by Centre of Chinese Medicine, Georgia:

Bronchial asthma; Oxcarbazepine; Antiepileptic drug; Efficacy

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Oxcarbazepine; Carbamazepine; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers	Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 Enzyme Inducers; Antimanic Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Psychotropic Drugs; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents