search
Back to results

Evaluation of the Effect of Levalbuterol on Allergen Induced Airway Inflammation In Subjects With Atopic Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
R-albuterol, S-albuterol
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring levalbuterol, asthma, allergen provocation, airway inflammation, clinical trial

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female (medically or surgically postmenopausal or practicing an accepted form of barrier or hormonal contraception) subjects age 18-55. Stable, mild atopic asthma with forced expiratory volume in one second (FEV1.0) greater than 70% of predicted for age and height, and not requiring any medical treatment other than short acting inhaled beta-agonists as needed. No recent or significant history of cigarette smoking (no cigarettes within six months prior to entry into the study; less than 10 pack-years cumulative history of cigarette smoking). Peak decrease in FEV1 in both early (0-2 hour) and late (3-7 hour) allergen-provoked response of > 15% compared with the baseline (pre-allergen challenge) spirometric determination. Signed written informed consent to participate in the protocol; ability to return to the outpatient clinic for repeated clinic visits. No history of asthma exacerbations or acute intercurrent respiratory illness (viral respiratory syndrome, bronchitis, pneumonia) for a six week period preceding entry into the screening phase of the study. Exclusion Criteria: Significant gastrointestinal (including hepatic), hematological, cardiovascular, cerebrovascular or other body system disorder. History of an acute exacerbation, or of a respiratory tract infection at any time during the past 6 weeks. Baseline AST or ALT (indicators of liver damage) greater than twice the upper limit of the normal range for the local laboratory. History of allergy or hypersensitivity to short-acting beta-agonists. Inability to discontinue asthma medications for the duration of the study or receipt of oral or inhaled corticosteroids or leukotriene receptor antagonist in the three weeks prior to entry into the screening phase of the study. Recent (within the past 2 months) or planned (within the study period) lung volume reduction surgery. Psychosis, alcoholism, active substance abuse, or any personality disorder which would make compliance with this protocol problematic. Pregnant or nursing females. Any other medical or social condition which, in the opinion of the investigator, could confound the interpretation of the data derived from this study.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The change in airway eosinophil number (% and absolute numbers) following an allergen inhalation.

    Secondary Outcome Measures

    Changes in:
    PC20 methacholine
    Allergen-induced early and late asthma responses
    Airway eosinophil activation (EG-2+ eosinophils)
    Levels of IL-5, RANTES, and eotaxin in sputum
    Expression of PLCß1 on airway eosinophils

    Full Information

    First Posted
    April 27, 2006
    Last Updated
    February 28, 2011
    Sponsor
    Hamilton Health Sciences Corporation
    Collaborators
    Sumitomo Pharma America, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00320034
    Brief Title
    Evaluation of the Effect of Levalbuterol on Allergen Induced Airway Inflammation In Subjects With Atopic Asthma
    Official Title
    Double-blind, Crossover, Placebo-controlled Evaluation of the Effect of Levalbuterol (R-albuterol) on Allergen Induced Airway Inflammation In Subjects With Atopic Asthma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2006 (undefined)
    Primary Completion Date
    June 2008 (Actual)
    Study Completion Date
    November 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Hamilton Health Sciences Corporation
    Collaborators
    Sumitomo Pharma America, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    The most commonly used drug for immediate relief of symptoms of asthma is the blue puffer, albuterol or salbutamol (Ventolin). Racemic albuterol is a mixture of two forms of albuterol which are mirror images of each other i.e. R-and S- isomers. The investigational treatments are R-albuterol and S-albuterol. R-albuterol ( levalbuterol) has been shown to have a slightly better bronchodilator effect as compared to the racemic albuterol and is well- tolerated in patients. However it is still not clear whether the S-isomer has no effect or has a harmful effect on the airways. The purpose of this study is to compare the effects of the R- and S- isomers on allergen induced airway inflammation in subjects with mild atopic asthma. This will give us a better idea as to whether the routine use of levalbuterol is superior to racemic albuterol.
    Detailed Description
    The most commonly used drug for immediate relief of symptoms of asthma is the blue puffer, albuterol or salbutamol (Ventolin). Racemic albuterol is a mixture of two forms of albuterol which are mirror images of each other i.e. R-and S- isomers. The investigational treatments are R-albuterol and S-albuterol . R-albuterol ( levalbuterol) relieves the narrowing of the bronchial air passages in the lungs and has been approved by the U.S. FDA, but is not currently licensed for use in Canada. We have obtained approval from Health Canada to use these isomers for the purpose of this study. R-albuterol has been shown to have a slightly better bronchodilator effect as compared to the racemic albuterol and is well- tolerated in patients, with only a few mild to moderate side effects (such as palpitations, diarrhoea, abdominal pain, bodyache, leg cramps and headache). However it is still not clear whether the S-isomer has no effect or has a harmful effect on the airways. The purpose of this study is to determine the effect of this drug, levalbuterol, on the allergen-induced inflammatory response in adult subjects with asthma. Specifically, we want to look for changes in airway eosinophils by examining sputum samples and to compare the effects of the R- and S- isomers on airway inflammation. This will help us to understand whether the racemic albuterol could worsen inflammation because of the presence of the S-isomer, and this will give us a better idea as to whether the routine use of levalbuterol is superior to racemic albuterol.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma
    Keywords
    levalbuterol, asthma, allergen provocation, airway inflammation, clinical trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    R-albuterol, S-albuterol
    Primary Outcome Measure Information:
    Title
    The change in airway eosinophil number (% and absolute numbers) following an allergen inhalation.
    Secondary Outcome Measure Information:
    Title
    Changes in:
    Title
    PC20 methacholine
    Title
    Allergen-induced early and late asthma responses
    Title
    Airway eosinophil activation (EG-2+ eosinophils)
    Title
    Levels of IL-5, RANTES, and eotaxin in sputum
    Title
    Expression of PLCß1 on airway eosinophils

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female (medically or surgically postmenopausal or practicing an accepted form of barrier or hormonal contraception) subjects age 18-55. Stable, mild atopic asthma with forced expiratory volume in one second (FEV1.0) greater than 70% of predicted for age and height, and not requiring any medical treatment other than short acting inhaled beta-agonists as needed. No recent or significant history of cigarette smoking (no cigarettes within six months prior to entry into the study; less than 10 pack-years cumulative history of cigarette smoking). Peak decrease in FEV1 in both early (0-2 hour) and late (3-7 hour) allergen-provoked response of > 15% compared with the baseline (pre-allergen challenge) spirometric determination. Signed written informed consent to participate in the protocol; ability to return to the outpatient clinic for repeated clinic visits. No history of asthma exacerbations or acute intercurrent respiratory illness (viral respiratory syndrome, bronchitis, pneumonia) for a six week period preceding entry into the screening phase of the study. Exclusion Criteria: Significant gastrointestinal (including hepatic), hematological, cardiovascular, cerebrovascular or other body system disorder. History of an acute exacerbation, or of a respiratory tract infection at any time during the past 6 weeks. Baseline AST or ALT (indicators of liver damage) greater than twice the upper limit of the normal range for the local laboratory. History of allergy or hypersensitivity to short-acting beta-agonists. Inability to discontinue asthma medications for the duration of the study or receipt of oral or inhaled corticosteroids or leukotriene receptor antagonist in the three weeks prior to entry into the screening phase of the study. Recent (within the past 2 months) or planned (within the study period) lung volume reduction surgery. Psychosis, alcoholism, active substance abuse, or any personality disorder which would make compliance with this protocol problematic. Pregnant or nursing females. Any other medical or social condition which, in the opinion of the investigator, could confound the interpretation of the data derived from this study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Parameswaran Nair, MD
    Organizational Affiliation
    Firestone Institute for Respiratory Health, St. Joseph's Healthcare
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    11692096
    Citation
    Lotvall J, Palmqvist M, Arvidsson P, Maloney A, Ventresca GP, Ward J. The therapeutic ratio of R-albuterol is comparable with that of RS-albuterol in asthmatic patients. J Allergy Clin Immunol. 2001 Nov;108(5):726-31. doi: 10.1067/mai.2001.119152.
    Results Reference
    background
    PubMed Identifier
    10883742
    Citation
    Handley DA, Tinkelman D, Noonan M, Rollins TE, Snider ME, Caron J. Dose-response evaluation of levalbuterol versus racemic albuterol in patients with asthma. J Asthma. 2000 Jun;37(4):319-27. doi: 10.3109/02770900009055455.
    Results Reference
    background

    Learn more about this trial

    Evaluation of the Effect of Levalbuterol on Allergen Induced Airway Inflammation In Subjects With Atopic Asthma

    We'll reach out to this number within 24 hrs