Study of Efficacy of Sodium Valproate in Therapy of Bronchial Asthma - Full Text View

Sponsors and Collaborators:	Centre of Chinese Medicine, Georgia Rea Rehabilitation Centre, Georgia
Information provided by:	Centre of Chinese Medicine, Georgia
ClinicalTrials.gov Identifier:	NCT00153270

Purpose

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

Condition	Intervention	Phase
Bronchial Asthma	Drug: Sodium Valproate	Phase IV

MedlinePlus related topics: Asthma

Drug Information available for: Divalproex sodium Valproate Sodium Valproic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Sodium Valproate Efficacy in Asthma Therapy

Further study details as provided by Centre of Chinese Medicine, Georgia:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	46
Study Start Date:	September 2000
Estimated Study Completion Date:	April 2001

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 sodium valproate efficacy in therapy of bronchial asthma. Sodium Valproate is antiepileptic drug of new generation, initially produced by Sanofi Pharma. 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

Ages Eligible for Study:	16 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 emphysema.
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 protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153270

Sponsors and Collaborators

Centre of Chinese Medicine, Georgia

Rea Rehabilitation Centre, Georgia

Investigators

Principal Investigator:	Merab Lomia, MD	"Rea" Rehabilitation Centre
Study Chair:	Manana Tchaia, MD	Centre of Chinese Medicine

More Information

Website of Neuroasthma Group This link exits the ClinicalTrials.gov site

Study ID Numbers:	LPT-1000-SV-0201
Study First Received:	September 8, 2005
Last Updated:	May 15, 2006
ClinicalTrials.gov Identifier:	NCT00153270
Health Authority:	Georgia: Ministry of Health

Keywords provided by Centre of Chinese Medicine, Georgia:

Bronchial asthma
Sodium valproate
Antiepileptic drug
Efficacy

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Valproic Acid
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Bronchial Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants

Enzyme Inhibitors
Antimanic Agents
Pharmacologic Actions
Therapeutic Uses
GABA Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009