Antiepileptic Drug Carbamazepine in Treatment of Bronchial Asthma

Phase 4

Completed

• Conditions: Bronchial Asthma

• Registration Number: NCT00207428
• Lead Sponsor: Centre of Chinese Medicine, Georgia

Brief Summary

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

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 Timeline

• Status Verified: 1999-07
• Study Start: 1999-08
• Study Completion: 2000-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Last Update Submitted: 2006-05-15
• Last Update Posted: 2006-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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