Clinical trial NCT00142025: Study of Efficacy of Oxcarbazepine in Therapy of Bronchial Asthma
Official title: Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Oxcarbazepine Efficacy in Asthma Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bronchial Asthma
Keywords: Bronchial asthma
Oxcarbazepine
Antiepileptic drug
Efficacy
Lead sponsor: Centre of Chinese Medicine, Georgia
Sponsor class: OTHER
Collaborators: name: Rea Rehabilitation Centre, Georgia
First posted: 2005-09-02
Enrollment: 55
Sex: ALL
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether antiepileptic drug oxcarbazepine is effective in the treatment of chronic asthma.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: At 3 months of treatment: Change from baseline of the FEV1 and PEFR (also %predicted); Number of patients without asthma symptoms
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
Study officials:
affiliation: "Rea" Rehabilitation Centre.
name: Merab Lomia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre of Chinese Medicine
name: Manana Tchaia, MD
role: STUDY_DIRECTOR
affiliation: CRO Evidence
name: Tamara Tchelidze, MD
role: STUDY_CHAIR
References: