Study of Efficacy of Phenytoin in Therapy of Patients With Bronchial Asthma

Bronchial Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00327028
• Other study ID #: LTP-DP-0505-1205
• 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
• 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

• Asthma
• Bronchial Asthma

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

External Links

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