Study of Efficacy of Phenytoin in Therapy of Children With Bronchial Asthma - Full Text View

Sponsor:	Centre of Chinese Medicine, Georgia
Collaborator:	Rea Rehabilitation Centre, Georgia
Information provided by:	Centre of Chinese Medicine, Georgia
ClinicalTrials.gov Identifier:	NCT00366067

Purpose

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

Condition	Intervention	Phase
Bronchial Asthma	Drug: Phenytoin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: Asthma Rehabilitation

Drug Information available for: Phenytoin Phenytoin sodium

U.S. FDA Resources

Further study details as provided by Centre of Chinese Medicine, Georgia:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	50
Study Start Date:	August 2006
Study Completion Date:	February 2007

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.

Eligibility

Ages Eligible for Study:	4 Years to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
Patients able to use peak flow meters, to perform spirometry and to swallow capsules.
Patient aged between 4 and 14 years, males or females.
Out patients.
Patients with an established (i.e. at least 6 months) clinical history of asthma.
Absence of long-term remissions of asthma (lasting more than 1 month)
Poorly controlled asthma, due to various reasons.

Exclusion Criteria:

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.
Patients with active tuberculosis with indication for treatment.
Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis or if the abnormal defines a disease listed as an exclusion criterion.
Patients with known allergy, side effects, intolerance/hypersensitivity to investigational drug
Patients currently using MAO inhibitors, tricyclic antidepressants, antiepileptic drugs, narcotic agents.
Patients between 10 and 14, parents or supervisor of patients unlikely, unable or unwilling to comply with the requirements of the protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366067

Locations

Georgia
"Rea" Rehabilitation Centre
Tbilisi, Georgia, 0160

Sponsors and Collaborators

Centre of Chinese Medicine, Georgia

Rea Rehabilitation Centre, Georgia

Investigators

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

More Information

Additional Information:

Bronchial asthma as neurogenic paroxysmal inflammatory disorder This link exits the ClinicalTrials.gov site

Bronchial asthma as neurogenic paroxysmal inflammatory disease: a randomized trial with carbamazepine This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00366067 History of Changes
Other Study ID Numbers:	LTPZ-P-CH-0806-0107
Study First Received:	August 17, 2006
Last Updated:	February 18, 2009
Health Authority:	Georgia: Ministry of Health

Keywords provided by Centre of Chinese Medicine, Georgia:

Bronchial asthma
Phenytoin
Antiepileptic drugs
Efficacy

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate

Hypersensitivity
Immune System Diseases
Phenytoin
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012