Antiepileptic Drug Carbamazepine in Treatment of Bronchial Asthma

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00207428

Enrollment

Registered

2005-09-21

Start date

1999-08-31

Completion date

2000-04-30

Last updated

2006-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Asthma

Keywords

Bronchial asthma, Carbamazepine, Efficacy

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.

Interventions

DRUGCarbamazepine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026