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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00142025
Other study ID # LP-0501-OC-0302
Secondary ID
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
Est. primary completion date
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


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
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