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Sponsors and Collaborators: |
Hamilton Health Sciences Sepracor, Inc. |
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Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00320034 |
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.
Condition | Intervention | Phase |
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Asthma |
Drug: R-albuterol, S-albuterol |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 15 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | November 2007 |
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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Melanie Kjarsgaard, RRT | 9055221155 ext 33024 | mkjarsga@stjosham.on.ca |
Contact: Liesel D'silva, MD | 9055221155 ext 35818 | dsilval@mcmaster.ca |
Canada, Ontario | |
Firestone Institute for Respiratory Health, St. Joseph's Healthcare | Recruiting |
Hamilton, Ontario, Canada, L8N 4A6 | |
Contact: Melanie Kjarsgaard, RRT 9055221155 ext 33024 mkjarsga@stjosham.on.ca | |
Contact: Liesel D'silva, MD 9055221155 ext 35818 dsilval@mcmaster.ca | |
Principal Investigator: Parameswaran K Nair, MD |
Principal Investigator: | Parameswaran Nair, MD | Firestone Institute for Respiratory Health, St. Joseph's Healthcare |
Study ID Numbers: | SRC 192 |
Study First Received: | April 27, 2006 |
Last Updated: | October 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00320034 |
Health Authority: | Canada: Health Canada |
levalbuterol asthma allergen provocation airway inflammation clinical trial |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Albuterol |
Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity Inflammation |
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic beta-Agonists Bronchial Diseases Immune System Diseases Physiological Effects of Drugs Anti-Asthmatic Agents |
Reproductive Control Agents Adrenergic Agonists Pharmacologic Actions Pathologic Processes Tocolytic Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |