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Study of Efficacy of Lamotrigine in Therapy of Bronchial Asthma

Primary Purpose

Bronchial Asthma

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Lamotrigine
Sponsored by
Centre of Chinese Medicine, Georgia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchial Asthma focused on measuring Bronchial asthma, Lamotrigine, Antiepileptic drug, Efficacy

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. 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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    At 3 months of treatment: Change from baseline of the FEV1 and PEFR (also %predicted); Number of patients without asthma symptoms

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    September 8, 2005
    Last Updated
    February 18, 2009
    Sponsor
    Centre of Chinese Medicine, Georgia
    Collaborators
    Rea Rehabilitation Centre, Georgia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00153244
    Brief Title
    Study of Efficacy of Lamotrigine in Therapy of Bronchial Asthma
    Official Title
    Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Lamotrigine Efficacy in Asthma Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 2003 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Centre of Chinese Medicine, Georgia
    Collaborators
    Rea Rehabilitation Centre, Georgia

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether antiepileptic drug lamotrigine 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 double-blind placebo-controlled 3-month trial for evaluation of lamotrigine efficacy in therapy of poorly controlled bronchial asthma. Lamotrigine is antiepileptic drug of new generation, produced by Glaxo SmithCline. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bronchial Asthma
    Keywords
    Bronchial asthma, Lamotrigine, Antiepileptic drug, Efficacy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    76 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Lamotrigine
    Primary Outcome Measure Information:
    Title
    At 3 months of treatment: Change from baseline of the FEV1 and PEFR (also %predicted); Number of patients without asthma symptoms
    Secondary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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. 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Merab Lomia, MD, PhD
    Organizational Affiliation
    Rea Rehabilitation Centre, Georgia
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Manana Tchaia, MD
    Organizational Affiliation
    Centre of Chinese Medicine
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Tamara Tchelidze, MD
    Organizational Affiliation
    CRO Evidence
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.asthma.ge
    Description
    Website of Neuroasthma Group
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/16597501?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum
    Description
    Bronchial asthma as neurogenic paroxysmal inflammatory disease: a randomized trial with carbamazepine

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    Study of Efficacy of Lamotrigine in Therapy of Bronchial Asthma

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