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Study of Efficacy of Phenytoin in Therapy of Children 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: NCT00366067
Recruitment Status : Completed
First Posted : August 18, 2006
Last Update Posted : February 19, 2009
Rea Rehabilitation Centre, Georgia
Information provided by:
Centre of Chinese Medicine, Georgia

Brief Summary:
The purpose of this study was to determine whether antiepileptic drug phenytoin is effective in the treatment of chronic asthma in children.

Condition or disease Intervention/treatment Phase
Bronchial Asthma Drug: Phenytoin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Phenytoin Efficacy in Children for Therapy of Bronchial Asthma
Study Start Date : August 2006
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Primary Outcome Measures :
  1. At 3 months of treatment: Change from baseline of the FEV1 and PEFR (also %predicted); Number of patients without asthma symptoms

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00366067

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"Rea" Rehabilitation Centre
Tbilisi, Georgia, 0160
Sponsors and Collaborators
Centre of Chinese Medicine, Georgia
Rea Rehabilitation Centre, Georgia
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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

Additional Information:
Layout table for additonal information Identifier: NCT00366067    
Other Study ID Numbers: LTPZ-P-CH-0806-0107
First Posted: August 18, 2006    Key Record Dates
Last Update Posted: February 19, 2009
Last Verified: February 2009
Keywords provided by Centre of Chinese Medicine, Georgia:
Bronchial asthma
Antiepileptic drugs
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers