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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00327028
Recruitment Status : Completed
First Posted : May 17, 2006
Last Update Posted : February 19, 2009
Rea Rehabilitation Centre, Georgia
Information provided by:
Centre of Chinese Medicine, Georgia

Tracking Information
First Submitted Date  ICMJE May 15, 2006
First Posted Date  ICMJE May 17, 2006
Last Update Posted Date February 19, 2009
Study Start Date  ICMJE September 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2006)
  • At 3 months of treatment
  • Change from baseline of the PEFR and FEV1
  • Number of patients without asthma symptoms
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00327028 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2006)
  • At 3 months of treatment
  • FEV1 before and after salbutamol inhalation
  • The daily (daytime and night-time) symptoms scores
  • Use of other antiasthmatic medication
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Study of Efficacy of Phenytoin in Therapy of Patients With Bronchial Asthma
Official Title  ICMJE Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Phenytoin Efficacy in Bronchial Asthma Therapy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Bronchial Asthma
Intervention  ICMJE Drug: Diphenine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: May 15, 2006)
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00327028
Other Study ID Numbers  ICMJE LTP-DP-0505-1205
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Centre of Chinese Medicine, Georgia
Collaborators  ICMJE Rea Rehabilitation Centre, Georgia
Investigators  ICMJE
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
PRS Account Centre of Chinese Medicine, Georgia
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP