Bronchial AsthmaPhase 4NCT00153270
Study of Efficacy of Sodium Valproate in Therapy of Bronchial Asthma
A Phase 4 study testing Sodium Valproate in people with Bronchial Asthma, run by Centre of Chinese Medicine, Georgia.
Trial summary
The purpose of this study is to determine whether antiepileptic drug sodium valproate is effective in the treatment of chronic asthma. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- Sodium Valproate
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Sep 2000to Apr 2001
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients 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.
- Males or females.
- Patient aged between 16 and 65 years.
- Out patients.
- Non smokers or ex-smokers, having stopped smoking > 1 year.
- Patients with an established (i.e. at least one year) clinical history of asthma.
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- Absence of long-term remissions of asthma (lasting more than 1 month)
- Poorly controlled asthma, due to various reasons.
- Patients with a FEV1 reversibility of at least 12% from initial level after 400 mcg salbutamol inhalation (4 puffs of salbutamol MDI, 100 mcg per puff). Patients whose FEV1 reversibility was 12% within the past 12 months are acceptable, providing that the records are available to the investigator.
- Patients able to swallow capsules, able to understand and complete diary cards and to record their PEFR using a peak-flow meter.
Who cannot join
- Long-term history of smoking (3 years and more)
- 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 a recent history (< 1 year) of myocardial infarction and/or (< 3 years) of heart failure or patients with any cardiac arrhythmia requiring drug therapy.
- History of cancer within the past 5 years.
- Patients with active tuberculosis with indication for treatment.
- Patients with a history of cystic fibrosis, bronchiectasis, chronic bronchitis or emphysema.
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- 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.
- Pregnant or nursing women and sexually active women with childbearing potential not using a medically approved method of contraception.
- Patients unlikely, unable or unwilling to comply with the requirements of the protocol.
About this study
Official title: Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Sodium Valproate Efficacy in Asthma Therapy
The purpose of this study is to determine whether antiepileptic drug sodium valproate is effective in the treatment of chronic asthma.
Read the 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. But some other neurogenic inflammatory paroxysmal disorders exist, and they are migraine and trigeminal neuralgia. Some antiepileptic drugs, like carbamazepine and valproate, are very effective in therapy of migraine and trigeminal neuralgia - more than in 80% of cases. 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 performed a double-blind, placebo-controlled 3-month trial for evaluation of sodium valproate efficacy in therapy of bronchial asthma. Sodium Valproate is antiepileptic drug of new generation, initially produced by Sanofi Pharma. Comparison: Patients received investigational drug in addition to their usual routine antiasthmatic treatment, compared to patients received placebo in addition to their usual routine antiasthmatic treatment.
- Conditions
- Bronchial Asthma
- Being tested
- Sodium Valproate
- Keywords
- Bronchial asthma, Sodium valproate, Antiepileptic drug, Efficacy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium ValproateDrug
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 FEV1 and PEFR (also %predicted); Number of patients without asthma symptoms
Secondary outcomes (1)
At 3 months of treatment: FEV1 before and after salbutamol inhalation; 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2000
- Study completionApr 2001
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
- 46 participants
Sponsor and investigators
- Lead sponsor
- Centre of Chinese Medicine, Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- Rea Rehabilitation Centre, Georgia
- Investigators
- Merab Lomia, MD, Principal investigator, "Rea" Rehabilitation CentreManana Tchaia, MD, Study chair, Centre of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153270
- Sponsor's protocol ID
- LPT-1000-SV-0201
- Status last verified
- Feb 2009
- First submitted
- 8 Sep 2005
- 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 Sodium Valproate Efficacy in Asthma Therapy
- ClinicalTrials.gov ID
- NCT00153270
- Acronym / sponsor ID
- LPT-1000-SV-0201
- Conditions
- Bronchial Asthma
- Keywords
- Bronchial asthma, Sodium valproate, Antiepileptic drug, Efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants
- Lead sponsor
- Centre of Chinese Medicine, GeorgiaUniversity, hospital or other
- Collaborators
- Rea Rehabilitation Centre, Georgia
- Study start
- Sep 2000
- Study completion
- Apr 2001
- First posted
- 12 Sep 2005 (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 is to determine whether antiepileptic drug sodium valproate is effective in the treatment of chronic asthma.
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. But some other neurogenic inflammatory paroxysmal disorders exist, and they are migraine and trigeminal neuralgia. Some antiepileptic drugs, like carbamazepine and valproate, are very effective in therapy of migraine and trigeminal neuralgia - more than in 80% of cases. 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 performed a double-blind, placebo-controlled 3-month trial for evaluation of sodium valproate efficacy in therapy of bronchial asthma. Sodium Valproate is antiepileptic drug of new generation, initially produced by Sanofi Pharma. Comparison: Patients received investigational drug in addition to their usual routine antiasthmatic treatment, compared to patients received placebo in addition to their usual routine antiasthmatic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patients 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.
- Males or females.
- Patient aged between 16 and 65 years.
- Out patients.
- Non smokers or ex-smokers, having stopped smoking > 1 year.
Key exclusion criteria (11 listed)
- Long-term history of smoking (3 years and more)
- 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 a recent history (< 1 year) of myocardial infarction and/or (< 3 years) of heart failure or patients with any cardiac arrhythmia requiring drug therapy.
- History of cancer within the past 5 years.
- Patients with active tuberculosis with indication for treatment.
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 |
|---|---|---|
| Sodium Valproate | Drug | – |
Primary outcome
At 3 months of treatment: Change from baseline of the FEV1 and PEFR (also %predicted); Number of patients without asthma symptoms
1 secondary outcome
At 3 months of treatment: FEV1 before and after salbutamol inhalation; 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
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.
Merab Lomia, MD principal investigator
"Rea" Rehabilitation Centre
Manana Tchaia, MD study chair
Centre of Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium Valproate 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 10 inclusion and 11 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: Change from baseline of the FEV1 and PEFR (also %predicted); Number of patients without asthma symptoms. 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.