|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Centre of Chinese Medicine, Georgia |
|---|---|
| Collaborator: |
Rea Rehabilitation Centre, Georgia |
| Information provided by: | Centre of Chinese Medicine, Georgia |
| ClinicalTrials.gov Identifier: | NCT00142025 |
Purpose
The purpose of this study is to determine whether antiepileptic drug oxcarbazepine is effective in the treatment of chronic asthma.
| Condition | Intervention | Phase |
|---|---|---|
|
Bronchial Asthma |
Drug: Oxcarbazepine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Oxcarbazepine Efficacy in Asthma Therapy |
| Estimated Enrollment: | 55 |
| Study Start Date: | September 2001 |
| Estimated Study Completion Date: | March 2002 |
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.
Eligibility| Ages Eligible for Study: | 17 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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
| ClinicalTrials.gov Identifier: | NCT00142025 History of Changes |
| Other Study ID Numbers: | LP-0501-OC-0302 |
| Study First Received: | September 1, 2005 |
| Last Updated: | February 18, 2009 |
| Health Authority: | Georgia: Ministry of Health |
|
Bronchial asthma Oxcarbazepine Antiepileptic drug Efficacy |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Oxcarbazepine Carbamazepine Anticonvulsants |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |