Study of Efficacy of Sodium Valproate in Therapy of Bronchial Asthma
Information source: Centre of Chinese Medicine, Georgia
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bronchial Asthma
Intervention: Sodium Valproate (Drug)
Phase: Phase 4
Sponsored by: Centre of Chinese Medicine, Georgia
Official(s) and/or principal investigator(s):
Merab Lomia, MD, Principal Investigator, Affiliation: "Rea" Rehabilitation Centre
Manana Tchaia, MD, Study Chair, Affiliation: Centre of Chinese Medicine
The purpose of this study is to determine whether antiepileptic drug sodium valproate is
effective in the treatment of chronic asthma.
Official title: Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Sodium Valproate Efficacy in Asthma Therapy
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
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
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
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.
Minimum age: 16 Years.
Maximum age: 65 Years.
- 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.
- 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
- 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
Website of Neuroasthma Group
Starting date: September 2000
Ending date: April 2001
Last updated: May 15, 2006