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| Name | Class |
|---|---|
| Sumitomo Pharma America, Inc. | INDUSTRY |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R-albuterol, S-albuterol | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The change in airway eosinophil number (% and absolute numbers) following an allergen inhalation. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in: | ||
| PC20 methacholine | ||
| Allergen-induced early and late asthma responses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Parameswaran Nair, MD | Firestone Institute for Respiratory Health, St. Joseph's Healthcare | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11692096 | Background | 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. | |
| 10883742 | Background | 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. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Airway eosinophil activation (EG-2+ eosinophils) |
| Levels of IL-5, RANTES, and eotaxin in sputum |
| Expression of PLCß1 on airway eosinophils |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |