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

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ClinicalTrials.gov Identifier: NCT00366067
Recruitment Status : Completed
First Posted : August 18, 2006
Last Update Posted : February 19, 2009
Sponsor:
Collaborator:
Rea Rehabilitation Centre, Georgia
Information provided by:
Centre of Chinese Medicine, Georgia

Tracking Information
First Submitted Date  ICMJE August 17, 2006
First Posted Date  ICMJE August 18, 2006
Last Update Posted Date February 19, 2009
Study Start Date  ICMJE August 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2006)
At 3 months of treatment: Change from baseline of the FEV1 and PEFR (also %predicted); Number of patients without asthma symptoms
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00366067 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2006)
At 3 months of treatment: Difference in PEF pm-am (in %); The daily (daytime and night-time) symptoms scores; % of symptom free days during the treatment period; 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 Children With Bronchial Asthma
Official Title  ICMJE Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Phenytoin Efficacy in Children for Therapy of Bronchial Asthma
Brief Summary The purpose of this study was to determine whether antiepileptic drug phenytoin is effective in the treatment of chronic asthma in children.
Detailed Description

Effective therapy of asthma still remains quite serious problem. According GINA definition, asthma is an inflammatory disorder. Consequently, modern pharmacotherapy of asthma provides wide use of anti-inflammatory drugs. But asthma also is a paroxysmal disorder: many specialists and even some guidelines underline paroxysmal clinical picture of asthma. Besides this, according to some authors, neurogenic inflammation may play important role in asthma mechanism. It is known that some other neurogenic inflammatory paroxysmal disorders exist, and they are migraine and trigeminal neuralgia. Antiepileptic drug phenytoin is very effective in therapy of trigeminal neuralgia - more than in 70-80% of cases. Other antiepileptic drugs, salts of valproic acid, are effective in the treatment of migraine. If bronchial asthma also is paroxysmal inflammatory disease, like migraine and trigeminal neuralgia, it is possible that some antiepileptic drugs also are very effective in asthma therapy.

We perform a double-blind, placebo-controlled 3-month trial for evaluation of phenytoin efficacy in therapy of bronchial asthma in children. Phenytoin is a well-known, comparatively safe and effective antiepileptic drug with low cost. According our previous data, phenytoin is effective drug for asthma therapy in adults.

Comparison: children will receive investigational drug in addition to their usual routine antiasthmatic treatment, compared to patients received placebo in addition to their usual routine antiasthmatic treatment.

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: Phenytoin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 17, 2006)
50
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients between 10 and 14, patients parents or supervisors must have given their informed consent before commencing the procedures specified in the protocol, indicating that they understand the objectives of the study and are willing to adhere to the procedures described in the protocol.
  2. Patients able to use peak flow meters, to perform spirometry and to swallow capsules.
  3. Patient aged between 4 and 14 years, males or females.
  4. Out patients.
  5. Patients with an established (i.e. at least 6 months) clinical history of asthma.
  6. Absence of long-term remissions of asthma (lasting more than 1 month)
  7. Poorly controlled asthma, due to various reasons.

Exclusion Criteria:

  1. History or presence of cardiovascular, renal, neurologic, psychiatric, liver, immunologic, endocrine, infection or other diseases or dysfunctions if they are clinically significant. A clinically significant disease is defined as one which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
  2. Patients with active tuberculosis with indication for treatment.
  3. Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis or if the abnormal defines a disease listed as an exclusion criterion.
  4. Patients with known allergy, side effects, intolerance/hypersensitivity to investigational drug
  5. Patients currently using MAO inhibitors, tricyclic antidepressants, antiepileptic drugs, narcotic agents.
  6. Patients between 10 and 14, parents or supervisor of patients unlikely, unable or unwilling to comply with the requirements of the protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Georgia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00366067
Other Study ID Numbers  ICMJE LTPZ-P-CH-0806-0107
Has Data Monitoring Committee Yes
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
Principal Investigator: Merab Lomia, MD, PhD "Rea" Rehabilitation Centre
Principal Investigator: Tamuna Tchelidze CRO Evidence
Principal Investigator: Nana Zhorzholadze, MD "Rea" Rehabilitation Centre
Study Director: Manana Pruidze Centre of Chinese Medicine
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