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
About this trial
This is an interventional treatment trial for Bronchial Asthma focused on measuring Bronchial asthma, Phenytoin, Diphenine, Antiepileptic drugs, Efficacy
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
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
NCT ID
NCT00327028
First Posted
May 15, 2006
Last Updated
February 18, 2009
Sponsor
Centre of Chinese Medicine, Georgia
Collaborators
Rea Rehabilitation Centre, Georgia
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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