- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00327028
Study of Efficacy of Phenytoin in Therapy of Patients With Bronchial Asthma
February 18, 2009 updated by: Centre of Chinese Medicine, Georgia
Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Phenytoin Efficacy in Bronchial Asthma Therapy
The purpose of this study was evaluation the efficacy of antiepileptic drug phenytoin (diphenine) in the treatment of bronchial asthma.
Study Overview
Detailed Description
Effective therapy of asthma still remains quite serious problem.
According current opinion of leading specialists, asthma is an inflammatory disorder.
But asthma also is a paroxysmal disorder: many specialists underline paroxysmal clinical picture of asthma.
According to some authors, neurogenic inflammation may play important role in asthma mechanism.
But migraine and trigeminal neuralgia are also neurogenic inflammatory paroxysmal diseases, and some antiepileptic drugs, like diphenine and valproates, are very effective in therapy of these diseases - more than in 80% of cases.
If bronchial asthma also is paroxysmal inflammatory disease, we can suppose a possibility that some antiepileptic drugs also may show high efficacy in asthma therapy.
Taken in consideration this hypothesis, we performed a double-blind, placebo-controlled 3-month trial for evaluation of phenytoin (diphenine) efficacy in treatment of patients with bronchial asthma.
Study Type
Interventional
Enrollment
61
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Out patients
- Bronchial asthma has been known at least for 1 year
- Absence of long-term remissions of asthma (lasting more than 1 month)
- Poorly controlled asthma, due to various reasons
- Non-smokers
Exclusion Criteria:
- Presence of concomitant acute or chronic severe diseases
- Abnormal baseline haematology, blood chemistry or urinalysis
- Allergy or adverse reactions to investigational drug
- Age younger than 18 years old
- Long-term history of smoking
- Pregnancy or lactating
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
At 3 months of treatment
|
Change from baseline of the PEFR and FEV1
|
Number of patients without asthma symptoms
|
Secondary Outcome Measures
Outcome Measure |
---|
At 3 months of treatment
|
FEV1 before and after salbutamol inhalation
|
The daily (daytime and night-time) symptoms scores
|
Use of other antiasthmatic medication
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Tamara Tchelidze, MD, CRO Evidence
- Principal Investigator: Merab Lomia, MD, PhD, "Rea" Rehabilitation Centre
- Study Chair: Manana Pruidze, MD, PhD, Centre of Chinese Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Study Completion
December 1, 2005
Study Registration Dates
First Submitted
May 15, 2006
First Submitted That Met QC Criteria
May 15, 2006
First Posted (Estimate)
May 17, 2006
Study Record Updates
Last Update Posted (Estimate)
February 19, 2009
Last Update Submitted That Met QC Criteria
February 18, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LTP-DP-0505-1205
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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