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

Primary Purpose

Bronchial Asthma

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Diphenine
Sponsored by
Centre of Chinese Medicine, Georgia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchial Asthma focused on measuring Bronchial asthma, Phenytoin, Diphenine, Antiepileptic drugs, Efficacy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    May 15, 2006
    Last Updated
    February 18, 2009
    Sponsor
    Centre of Chinese Medicine, Georgia
    Collaborators
    Rea Rehabilitation Centre, Georgia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00327028
    Brief Title
    Study of Efficacy of Phenytoin in Therapy of Patients With Bronchial Asthma
    Official Title
    Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Phenytoin Efficacy in Bronchial Asthma Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Centre of Chinese Medicine, Georgia
    Collaborators
    Rea Rehabilitation Centre, Georgia

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bronchial Asthma
    Keywords
    Bronchial asthma, Phenytoin, Diphenine, Antiepileptic drugs, Efficacy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    61 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Diphenine
    Primary Outcome Measure Information:
    Title
    At 3 months of treatment
    Title
    Change from baseline of the PEFR and FEV1
    Title
    Number of patients without asthma symptoms
    Secondary Outcome Measure Information:
    Title
    At 3 months of treatment
    Title
    FEV1 before and after salbutamol inhalation
    Title
    The daily (daytime and night-time) symptoms scores
    Title
    Use of other antiasthmatic medication

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tamara Tchelidze, MD
    Organizational Affiliation
    CRO Evidence
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Manana Pruidze, MD, PhD
    Organizational Affiliation
    Centre of Chinese Medicine
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Merab Lomia, MD, PhD
    Organizational Affiliation
    "Rea" Rehabilitation Centre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.asthma.ge
    Description
    Website of Neuroasthma Group
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/16597501?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum
    Description
    Bronchial asthma as neurogenic paroxysmal inflammatory disease: a randomized trial with carbamazepine

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

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