Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320034
Status:
COMPLETED
Last Update Posted:
2011-03-02
First Post:
2006-04-27
Brief Title:
Evaluation of the Effect of Levalbuterol on Allergen Induced Airway Inflammation In Subjects With Atopic Asthma
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
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 ie 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 US 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
R-albuterol levalbuterol relieves the narrowing of the bronchial air passages in the lungs and has been approved by the US 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None