Study of Efficacy of Sodium Valproate in Therapy of Bronchial Asthma

Bronchial Asthma Clinical Trial

Official title:

Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Sodium Valproate Efficacy in Asthma Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00153270
• Other study ID #: LPT-1000-SV-0201
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: February 18, 2009
• Start date: September 2000
• Est. completion date: April 2001

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 sodium valproate 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

Drug:
• Sodium Valproate

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

External Links

•   Bronchial asthma as neurogenic paroxysmal inflammatory disease: a randomized trial with carbamazepine
•   Website of Neuroasthma Group