Status:
COMPLETED
Study of Efficacy of Phenytoin in Therapy of Children With Bronchial Asthma
Lead Sponsor:
Centre of Chinese Medicine, Georgia
Collaborating Sponsors:
Rea Rehabilitation Centre, Georgia
Conditions:
Bronchial Asthma
Eligibility:
All Genders
4-14 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00366067
Start Date
August 1 2006
End Date
February 1 2007
Last Update
February 19 2009
Active Locations (1)
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1
"Rea" Rehabilitation Centre
Tbilisi, Georgia, 0160