Bronchial AsthmaPhase 4NCT00327028
Study of Efficacy of Phenytoin in Therapy of Patients With Bronchial Asthma
A Phase 4 study testing Diphenine in people with Bronchial Asthma, run by Centre of Chinese Medicine, Georgia.
Trial summary
The purpose of this study was evaluation the efficacy of antiepileptic drug phenytoin (diphenine) in the treatment of bronchial asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- Diphenine
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Dec 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Bronchial Asthma
- Being tested
- Diphenine
- Keywords
- Bronchial asthma, Phenytoin, Diphenine, Antiepileptic drugs, Efficacy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiphenineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
At 3 months of treatment
Change from baseline of the PEFR and FEV1
Number of patients without asthma symptoms
Secondary outcomes (4)
At 3 months of treatment
FEV1 before and after salbutamol inhalation
The daily (daytime and night-time) symptoms scores
Use of other antiasthmatic medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2006 (estimated)
- Study startSep 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 61 participants
Sponsor and investigators
- Lead sponsor
- Centre of Chinese Medicine, Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- Rea Rehabilitation Centre, Georgia
- Investigators
- Tamara Tchelidze, MD, Study director, CRO EvidenceManana Pruidze, MD, PhD, Study chair, Centre of Chinese MedicineMerab Lomia, MD, PhD, Principal investigator, "Rea" Rehabilitation Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327028
- Sponsor's protocol ID
- LTP-DP-0505-1205
- Status last verified
- Feb 2009
- First submitted
- 15 May 2006
- Last updated
- 19 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Phenytoin Efficacy in Bronchial Asthma Therapy
- ClinicalTrials.gov ID
- NCT00327028
- Acronym / sponsor ID
- LTP-DP-0505-1205
- Conditions
- Bronchial Asthma
- Keywords
- Bronchial asthma, Phenytoin, Diphenine, Antiepileptic drugs, Efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants
- Lead sponsor
- Centre of Chinese Medicine, GeorgiaUniversity, hospital or other
- Collaborators
- Rea Rehabilitation Centre, Georgia
- Study start
- Sep 2005
- Study completion
- Dec 2005
- First posted
- 17 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was evaluation the efficacy of antiepileptic drug phenytoin (diphenine) in the treatment of bronchial asthma.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diphenine | Drug | – |
Primary outcome
At 3 months of treatment
Change from baseline of the PEFR and FEV1
Number of patients without asthma symptoms
4 secondary outcomes
At 3 months of treatment
FEV1 before and after salbutamol inhalation
The daily (daytime and night-time) symptoms scores
Use of other antiasthmatic medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2009.
- Website of Neuroasthma GroupLink provided by the sponsor.
- Bronchial asthma as neurogenic paroxysmal inflammatory disease: a randomized trial with carbamazepineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara Tchelidze, MD study director
CRO Evidence
Manana Pruidze, MD, PhD study chair
Centre of Chinese Medicine
Merab Lomia, MD, PhD principal investigator
"Rea" Rehabilitation Centre
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diphenine in people with Bronchial Asthma, run by Centre of Chinese Medicine, Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
At 3 months of treatment. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2009.