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

This study has been completed.
Sponsor:
Collaborator:
Rea Rehabilitation Centre, Georgia
Information provided by:
Centre of Chinese Medicine, Georgia
ClinicalTrials.gov Identifier:
NCT00327028
First received: May 15, 2006
Last updated: February 18, 2009
Last verified: February 2009
  Purpose

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


Condition Intervention Phase
Bronchial Asthma
Drug: Diphenine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Phenytoin Efficacy in Bronchial Asthma Therapy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • At 3 months of treatment
  • Change from baseline of the PEFR and FEV1
  • Number of patients without asthma symptoms

Secondary Outcome Measures:
  • At 3 months of treatment
  • FEV1 before and after salbutamol inhalation
  • The daily (daytime and night-time) symptoms scores
  • Use of other antiasthmatic medication

Estimated Enrollment: 61
Study Start Date: September 2005
Estimated Study Completion Date: December 2005
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327028

Sponsors and Collaborators
Centre of Chinese Medicine, Georgia
Rea Rehabilitation Centre, Georgia
Investigators
Study Director: Tamara Tchelidze, MD CRO Evidence
Study Chair: Manana Pruidze, MD, PhD Centre of Chinese Medicine
Principal Investigator: Merab Lomia, MD, PhD "Rea" Rehabilitation Centre
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00327028     History of Changes
Other Study ID Numbers: LTP-DP-0505-1205
Study First Received: May 15, 2006
Last Updated: February 18, 2009
Health Authority: Georgia: Ministry of Health

Keywords provided by Centre of Chinese Medicine, Georgia:
Bronchial asthma
Phenytoin, Diphenine
Antiepileptic drugs
Efficacy

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Phenytoin
Anticonvulsants
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 20, 2014