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Sponsors and Collaborators: |
Centre of Chinese Medicine, Georgia Rea Rehabilitation Centre, Georgia |
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Information provided by: | Centre of Chinese Medicine, Georgia |
ClinicalTrials.gov Identifier: | NCT00153296 |
The purpose of this study was to determine whether antiepileptic drug carbamazepine is effective in the treatment of chronic moderate persistent and severe asthma.
Condition | Intervention | Phase |
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Bronchial Asthma |
Drug: Carbamazepine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Carbamazepine Efficacy in Moderate Persistent and Severe Asthma Therapy |
Estimated Enrollment: | 68 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | April 2005 |
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 carbamazepine efficacy in therapy of bronchial asthma. Carbamazepine is a well-known, comparatively safe and effective antiepileptic drug. 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.
Ages Eligible for Study: | 16 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Merab Lomia, MD, PhD | "Rea" Rehabilitation Centre |
Study Director: | Tamuna Tchelidze, MD | CRO Evidence |
Study Chair: | Manana Tchaia, MD | Centre of Chinese Medicine |
Study ID Numbers: | LTP-1004-CZ-0405 |
Study First Received: | September 8, 2005 |
Last Updated: | February 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00153296 History of Changes |
Health Authority: | Georgia: Ministry of Health |
Bronchial asthma Carbamazepine Antiepileptic drugs Efficacy |
Tranquilizing Agents Bronchial Diseases Psychotropic Drugs Central Nervous System Depressants Asthma Antimanic Agents Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases |
Carbamazepine Analgesics, Non-Narcotic Lung Diseases Hypersensitivity, Immediate Analgesics Peripheral Nervous System Agents Anticonvulsants Respiratory Hypersensitivity |
Tranquilizing Agents Bronchial Diseases Immune System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Asthma Antimanic Agents Pharmacologic Actions Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases |
Carbamazepine Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Analgesics Central Nervous System Agents Anticonvulsants Respiratory Hypersensitivity |