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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00327028
Other study ID # LTP-DP-0505-1205
Secondary ID
Status Completed
Phase Phase 4
First received May 15, 2006
Last updated February 18, 2009
Start date September 2005
Est. completion date December 2005

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 was evaluation the efficacy of antiepileptic drug phenytoin (diphenine) in the treatment of bronchial asthma.


Description:

Effective therapy of asthma still remains quite serious problem. According current opinion of leading specialists, asthma is an inflammatory disorder. But asthma also is a paroxysmal disorder: many specialists underline paroxysmal clinical picture of asthma. According to some authors, neurogenic inflammation may play important role in asthma mechanism. But migraine and trigeminal neuralgia are also neurogenic inflammatory paroxysmal diseases, and some antiepileptic drugs, like diphenine and valproates, are very effective in therapy of these diseases - more than in 80% of cases. If bronchial asthma also is paroxysmal inflammatory disease, we can suppose a possibility that some antiepileptic drugs also may show high efficacy in asthma therapy. Taken in consideration this hypothesis, we performed a double-blind, placebo-controlled 3-month trial for evaluation of phenytoin (diphenine) efficacy in treatment of patients with bronchial asthma.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Out patients

- 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 acute or chronic severe diseases

- Abnormal baseline haematology, blood chemistry or urinalysis

- Allergy or adverse reactions to investigational drug

- Age younger than 18 years old

- Long-term history of smoking

- Pregnancy or lactating

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Diphenine


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
Primary Change from baseline of the PEFR and FEV1
Primary Number of patients without asthma symptoms
Secondary At 3 months of treatment
Secondary FEV1 before and after salbutamol inhalation
Secondary The daily (daytime and night-time) symptoms scores
Secondary Use of other antiasthmatic medication
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