Study of Efficacy of Oxcarbazepine in Therapy of Bronchial Asthma
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| ClinicalTrials.gov Identifier: NCT00142025 |
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Recruitment Status :
Completed
First Posted : September 2, 2005
Last Update Posted : February 19, 2009
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bronchial Asthma | Drug: Oxcarbazepine | Phase 4 |
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 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 |
- At 3 months of treatment: Change from baseline of the FEV1 and PEFR (also %predicted); Number of patients without asthma symptoms
- 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
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| Ages Eligible for Study: | 17 Years to 75 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00142025
| 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 |
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00142025 History of Changes |
| Other Study ID Numbers: |
LP-0501-OC-0302 |
| First Posted: | September 2, 2005 Key Record Dates |
| Last Update Posted: | February 19, 2009 |
| Last Verified: | February 2009 |
Keywords provided by Centre of Chinese Medicine, Georgia:
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Bronchial asthma Oxcarbazepine Antiepileptic drug Efficacy |
Additional relevant MeSH terms:
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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 |