Study of Efficacy of Oxcarbazepine in Therapy of Bronchial Asthma

Bronchial Asthma Clinical Trial

Official title:

Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Oxcarbazepine Efficacy in Asthma Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00142025
• Other study ID #: LP-0501-OC-0302
• Status: Completed
• Phase: Phase 4
• First received: September 1, 2005
• Last updated: February 18, 2009
• Start date: September 2001
• Est. completion date: March 2002

Study information

• Verified date: February 2009
• 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 is to determine whether antiepileptic drug oxcarbazepine is effective in the treatment of chronic asthma.

Description:

Effective therapy of asthma still remains quite serious problem. According GINA definition, asthma is an inflammatory disorder. Consequently, modern pharmacotherapy of asthma provides wide use of anti-inflammatory drugs. But asthma also is a paroxysmal disorder: many specialists and even some guidelines underline paroxysmal clinical picture of asthma. Besides this, according to some authors, neurogenic inflammation may play important role in asthma mechanism. But some other neurogenic inflammatory paroxysmal disorders exist, and they are migraine and trigeminal neuralgia. Some antiepileptic drugs, like carbamazepine and valproate, are very effective in therapy of migraine and trigeminal neuralgia - more than in 80% of cases. If bronchial asthma also is paroxysmal inflammatory disease, like migraine and trigeminal neuralgia, it is possible that some antiepileptic drugs also are very effective in asthma therapy.

We performed a double-blind, placebo-controlled 3-month trial for evaluation of oxcarbazepine efficacy in therapy of bronchial asthma. Oxcarbazepine is antiepileptic drug of new generation, produced by Novartis, and it is more effective and safe derivative of well-known antiepileptic drug carbamazepine.

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: 55
• Est. completion date: March 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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 severe diseases

• Allergy or adverse reactions to carbamazepine or oxcarbazepine

• Abnormal baseline haematology, blood chemistry or urinalysis

• Current use of long-acting beta-agonists

• 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:
• Oxcarbazepine

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 FEV1 and PEFR (also %predicted); Number of patients without asthma symptoms
Secondary	At 3 months of treatment: FEV1 before and after salbutamol inhalation; Difference in PEF pm-am (in %); The daily (daytime and night-time) symptoms scores; % of symptom free days during the treatment period; Use of other antiasthmatic medication

External Links

•   Bronchial asthma as neurogenic paroxysmal inflammatory disease: a randomized trial with carbamazepine
•   Website of Neuroasthma Group