Antiepileptic Drug Carbamazepine in Treatment of Bronchial Asthma
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| ClinicalTrials.gov Identifier: NCT00207428 |
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Recruitment Status :
Completed
First Posted : September 21, 2005
Last Update Posted : May 16, 2006
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bronchial Asthma | Drug: Carbamazepine | Phase 4 |
Effective therapy of asthma still remains quite serious problem. According current opinion of leading specialists, asthma is an inflammatory disorder. But asthma also is a paroxysmal disorder: many specialists underline paroxysmal clinical picture of asthma. According to some authors, neurogenic inflammation may play important role in asthma mechanism. But migraine and trigeminal neuralgia are also neurogenic inflammatory paroxysmal diseases, and some antiepileptic drugs, like carbamazepine and valproates, are very effective in therapy of these diseases - more than in 80% of cases. If bronchial asthma also is paroxysmal inflammatory disease, we can suppose a possibility that some antiepileptic drugs also may show high efficacy in asthma therapy. Taken in consideration this hypothesis, we performed a double-blind, placebo-controlled 3-month trial for evaluation of carbamazepine efficacy in treatment of patients with mild-to-severe bronchial asthma.
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 : | 65 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | Randomized, Placebo Controlled, Double Blind Study of Carbamazepine in Treatment of Bronchial Asthma |
| Study Start Date : | August 1999 |
| Study Completion Date : | April 2000 |
- At 3 months of treatment: Change from baseline of the PEFR (also %predicted); Number of patients without asthma symptoms
- At 3 months of treatment: PEFR before and after salbutamol inhalation;
- Difference in PEFR pm-am (in %); The daily (daytime and night-time) symptoms scores; Use of other antiasthmatic medication
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Out patients
- 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 acute or chronic severe diseases
- Abnormal baseline haematology, blood chemistry or urinalysis
- Allergy or adverse reactions to investigational drug
- 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): NCT00207428
| Principal Investigator: | Merab Lomia, MD, PhD | "Rea" Rehabilitation Centre | |
| Study Director: | Manana Tchaia, MD | Centre of Chinese Medicine |
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00207428 History of Changes |
| Other Study ID Numbers: |
LP-CZ-0999-0400 |
| First Posted: | September 21, 2005 Key Record Dates |
| Last Update Posted: | May 16, 2006 |
| Last Verified: | July 1999 |
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Bronchial asthma Carbamazepine Efficacy |
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Carbamazepine Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Anticonvulsants |
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 Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |