Antiepileptic Drug Carbamazepine in Treatment of Bronchial Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-08-31

Study Completion Date

2000-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Bronchial Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Carbamazepine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Merab Lomia, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

"Rea" Rehabilitation Centre

Manana Tchaia, MD

Role: STUDY_DIRECTOR

Centre of Chinese Medicine

Other Identifiers

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LP-CZ-0999-0400

Identifier Type: -

Identifier Source: org_study_id