Study of Efficacy of Phenytoin in Therapy of Children With Bronchial Asthma
Information source: Centre of Chinese Medicine, Georgia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bronchial Asthma
Intervention: Phenytoin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Centre of Chinese Medicine, Georgia Official(s) and/or principal investigator(s): Merab Lomia, MD, PhD, Principal Investigator, Affiliation: "Rea" Rehabilitation Centre Tamuna Tchelidze, Principal Investigator, Affiliation: CRO Evidence Nana Zhorzholadze, MD, Principal Investigator, Affiliation: "Rea" Rehabilitation Centre Manana Pruidze, Study Director, Affiliation: Centre of Chinese Medicine
Summary
The purpose of this study was to determine whether antiepileptic drug phenytoin is effective
in the treatment of chronic asthma in children.
Clinical Details
Official title: Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Phenytoin Efficacy in Children for Therapy of Bronchial Asthma
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: At 3 months of treatment: Change from baseline of the FEV1 and PEFR (also %predicted); Number of patients without asthma symptoms
Secondary outcome: 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
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
Minimum age: 4 Years.
Maximum age: 14 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
"Rea" Rehabilitation Centre, Tbilisi 0160, Georgia
Additional Information
Bronchial asthma as neurogenic paroxysmal inflammatory disorder Bronchial asthma as neurogenic paroxysmal inflammatory disease: a randomized trial with carbamazepine
Starting date: August 2006
Last updated: February 18, 2009
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