Antiepileptic Drug Carbamazepine in Treatment of Bronchial Asthma

May 15, 2006 updated by: Centre of Chinese Medicine, Georgia

Randomized, Placebo Controlled, Double Blind Study of Carbamazepine in Treatment of Bronchial Asthma

The purpose of this study was evaluation the efficacy of antiepileptic drug carbamazepine in the treatment of mild-to-severe bronchial asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

65

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre of Chinese Medicine, Georgia

Collaborators

Rea Rehabilitation Centre, Georgia

Investigators

  • Principal Investigator: Merab Lomia, MD, PhD, "Rea" Rehabilitation Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1999

Study Completion

April 1, 2000

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

May 16, 2006

Last Update Submitted That Met QC Criteria

May 15, 2006

Last Verified

July 1, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LP-CZ-0999-0400

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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