Antiepileptic Drug Carbamazepine in Treatment of Bronchial Asthma

Bronchial Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00207428
• Other study ID #: LP-CZ-0999-0400
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: May 15, 2006
• Start date: August 1999
• Est. completion date: April 2000

Study information

• Verified date: July 1999
• Source: Centre of Chinese Medicine, Georgia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Georgia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

Drug:
• Carbamazepine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre of Chinese Medicine, Georgia	Rea Rehabilitation Centre, Georgia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	At 3 months of treatment: Change from baseline of the PEFR (also %predicted); Number of patients without asthma symptoms
Secondary	At 3 months of treatment: PEFR before and after salbutamol inhalation;
Secondary	Difference in PEFR pm-am (in %); The daily (daytime and night-time) symptoms scores; Use of other antiasthmatic medication

External Links

•   Website of Neuroasthma Group