Study of Efficacy of Oxcarbazepine in Therapy 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:
NCT00142025
First received: September 1, 2005
Last updated: February 18, 2009
Last verified: February 2009
  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 4

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

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 FEV1 and PEFR (also %predicted); Number of patients without asthma symptoms

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 55
Study Start Date: September 2001
Estimated Study Completion Date: March 2002
Detailed Description:

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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142025

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
Study Chair: Tamara Tchelidze, MD CRO Evidence
  More Information

Additional Information:
No publications provided

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

Keywords provided by Centre of Chinese Medicine, Georgia:
Bronchial asthma
Oxcarbazepine
Antiepileptic drug
Efficacy

Additional relevant MeSH terms:
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
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
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

ClinicalTrials.gov processed this record on September 15, 2014