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Study of Efficacy of Lamotrigine in Therapy of Bronchial Asthma

Information source: Centre of Chinese Medicine, Georgia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bronchial Asthma

Intervention: Lamotrigine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Centre of Chinese Medicine, Georgia

Official(s) and/or principal investigator(s):
Merab Lomia, MD, PhD, Principal Investigator, Affiliation: Rea Rehabilitation Centre, Georgia
Manana Tchaia, MD, Study Chair, Affiliation: Centre of Chinese Medicine
Tamara Tchelidze, MD, Study Director, Affiliation: CRO Evidence


The purpose of this study is to determine whether antiepileptic drug lamotrigine is effective in the treatment of chronic asthma.

Clinical Details

Official title: Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Lamotrigine Efficacy in Asthma Therapy

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

Primary outcome: At 3 months of treatment: Change from baseline of the FEV1 and PEFR (also %predicted); Number of patients without asthma symptoms

Secondary outcome: 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

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 double-blind placebo-controlled 3-month trial for evaluation of lamotrigine efficacy in therapy of poorly controlled bronchial asthma. Lamotrigine is antiepileptic drug of new generation, produced by Glaxo SmithCline. 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.


Minimum age: 16 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- Patients must have given their informed consent before commencing the procedures

specified in the protocol, indicating that they understand the objectives of the study and are willing to adhere to the procedures described in the protocol.

- Males or females.

- Patient aged between 16 and 65 years.

- Out patients.

- Non smokers or ex-smokers, having stopped smoking > 1 year.

- Patients with an established (i. e. at least one year) clinical history of asthma.

- Absence of long-term remissions of asthma (lasting more than 1 month)

- Poorly controlled asthma, due to various reasons.

- Patients with a FEV1 reversibility of at least 12% from initial level after 400 mcg

salbutamol inhalation (4 puffs of salbutamol MDI, 100 mcg per puff). Patients whose FEV1 reversibility was 12% within the past 12 months are acceptable, providing that the records are available to the investigator.

- Patients able to swallow capsules, able to understand and complete diary cards and to

record their PEFR using a peak-flow meter. Exclusion Criteria:

- Long-term history of smoking (3 years and more)

- History or presence of cardiovascular, renal, neurologic, psychiatric, liver,

immunologic, endocrine, infection or other diseases or dysfunctions if they are clinically significant. A clinically significant disease is defined as one which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.

- Patients with a recent history (< 1 year) of myocardial infarction and/or (< 3 years)

of heart failure or patients with any cardiac arrhythmia requiring drug therapy.

- History of cancer within the past 5 years.

- Patients with active tuberculosis with indication for treatment.

- Patients with a history of cystic fibrosis, bronchiectasis, chronic bronchitis or


- Patients with clinically significant abnormal baseline haematology, blood chemistry

or urinalysis or if the abnormal defines a disease listed as an exclusion criterion.

- Patients with known allergy, side effects, intolerance/hypersensitivity to

investigational drug

- Patients currently using MAO inhibitors, tricyclic antidepressants, antiepileptic

drugs, narcotic agents.

- Pregnant or nursing women and sexually active women with childbearing potential not

using a medically approved method of contraception.

- Patients unlikely, unable or unwilling to comply with the requirements of the


Locations and Contacts

Additional Information

Website of Neuroasthma Group

Bronchial asthma as neurogenic paroxysmal inflammatory disease: a randomized trial with carbamazepine

Starting date: August 2002
Last updated: February 18, 2009

Page last updated: August 23, 2015

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