Antiepileptic Drug Carbamazepine in Treatment of Bronchial Asthma

This study has been completed.
Sponsor:
Collaborator:
Rea Rehabilitation Centre, Georgia
Information provided by:
Centre of Chinese Medicine, Georgia
ClinicalTrials.gov Identifier:
NCT00207428
First received: September 13, 2005
Last updated: May 15, 2006
Last verified: July 1999
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00207428

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00207428     History of Changes
Other Study ID Numbers: LP-CZ-0999-0400
Study First Received: September 13, 2005
Last Updated: May 15, 2006
Health Authority: Georgia: Ministry of Health

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Carbamazepine
Analgesics
Analgesics, Non-Narcotic
Anticonvulsants
Antimanic Agents
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 21, 2014