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Antiepileptic Drug Carbamazepine in Treatment of Bronchial Asthma

This study has been completed.
Rea Rehabilitation Centre, Georgia
Information provided by:
Centre of Chinese Medicine, Georgia Identifier:
First received: September 13, 2005
Last updated: May 15, 2006
Last verified: July 1999
The purpose of this study was evaluation the efficacy of antiepileptic drug carbamazepine in the treatment of mild-to-severe bronchial asthma.

Condition Intervention Phase
Bronchial Asthma Drug: Carbamazepine Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Centre of Chinese Medicine, Georgia:

Primary Outcome Measures:
  • At 3 months of treatment: Change from baseline of the PEFR (also %predicted); Number of patients without asthma symptoms

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 65
Study Start Date: August 1999
Estimated Study Completion Date: April 2000
Detailed Description:

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.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
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
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Please refer to this study by its identifier: NCT00207428

Sponsors and Collaborators
Centre of Chinese Medicine, Georgia
Rea Rehabilitation Centre, Georgia
Principal Investigator: Merab Lomia, MD, PhD "Rea" Rehabilitation Centre
Study Director: Manana Tchaia, MD Centre of Chinese Medicine
  More Information

Additional Information: Identifier: NCT00207428     History of Changes
Other Study ID Numbers: LP-CZ-0999-0400
Study First Received: September 13, 2005
Last Updated: May 15, 2006

Keywords provided by Centre of Chinese Medicine, Georgia:
Bronchial asthma

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action processed this record on September 19, 2017