- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00153296
Study of Efficacy of Carbamazepine in Therapy of Patients With Moderate Persistent and Severe Bronchial Asthma
Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Carbamazepine Efficacy in Moderate Persistent and Severe Asthma Therapy
Study Overview
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 carbamazepine efficacy in therapy of bronchial asthma. Carbamazepine is a well-known, comparatively safe and effective antiepileptic drug.
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 Type
Enrollment
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- Moderate persistent or severe asthma, according GINA classification
- Patients with an established (i.e. at least one year) clinical history of asthma.
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
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 FEV1 and PEFR (also %predicted); Number of patients without asthma symptoms
|
Secondary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Manana Tchaia, MD, Centre of Chinese Medicine
- Principal Investigator: Merab Lomia, MD, PhD, "Rea" Rehabilitation Centre
- Study Director: Tamuna Tchelidze, MD, CRO Evidence
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anticonvulsants
- Sodium Channel Blockers
- Antimanic Agents
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Carbamazepine
Other Study ID Numbers
- LTP-1004-CZ-0405
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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