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Sponsored by: |
Brigham and Women's Hospital |
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Information provided by: | Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT00595361 |
The purpose of the study is to find out how well a long-acting beta agonist like salmeterol works in people with different forms of the same gene. Our hypothesis is that asthmatics with the Arg/Arg genotype will have loss of bronchoprotection against exercise-induced asthma with regular salmeterol treatment, as compared to asthmatics with the Gly/Gly genotype.
Condition | Intervention |
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Asthma |
Drug: salmeterol |
Study Type: | Interventional |
Study Design: | Treatment, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Effect of Beta-2 Adrenergic Polymorphisms on the Bronchoprotective Effects of Regular Salmeterol Treatment in Asthma |
Estimated Enrollment: | 30 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arg/Arg: Active Comparator
Arg/Arg subjects on 2 week salmeterol treatment
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Drug: salmeterol
salmeterol 50 micrograms twice daily for 2 weeks
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Gly/Gly: Active Comparator
Gly/Gly subjects on 2 week salmeterol treatment
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Drug: salmeterol
salmeterol 50 micrograms twice daily for 2 weeks
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In many patients with asthma, exercise-induced bronchoconstriction is a common and oftentimes limiting characteristic. Inhaled β2-adrenoreceptor agonists like albuterol are the most effective treatments available for the relief of acute asthma symptoms. However, there is evidence that regular use may lead to adverse effects in some patients. Previous studies have shown that polymorphisms of the β2-adrenergic receptor can influence airway responses to regular inhaled beta-agonist treatment.
Pharmacogenetics is the study of how genetic differences influence the variability in patients' responses to therapy, both therapeutic and adverse. Genetic susceptibility and environmental factors both play major roles in the etiology of asthma. The strong familial clustering of asthma has lead to a surge of research into the genetic predisposition of asthma. The aim of the present study is to utilize a double-blinded prospective cohort study to investigate whether genotype-specific effects occur when assessing the duration of protection conferred against exercise-induced bronchoconstriction by regular salmeterol treatment.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Perdita Permaul, M.D. | 617-732-8201 | PPermaul@partners.org |
United States, Massachusetts | |
Asthma Research Center, Brigham and Women's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Sub-Investigator: Perdita Permaul, M.D. |
Principal Investigator: | Elliot Israel, M.D. | Asthma Research Center, Brigham and Women's Hospital |
Responsible Party: | Asthma Research Center/Brigham and Women's Hospital ( Elliot Israel, M.D. ) |
Study ID Numbers: | 2007-P-002199 |
Study First Received: | January 7, 2008 |
Last Updated: | March 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00595361 |
Health Authority: | United States: Institutional Review Board |
asthma exercise induced asthma exercise induced bronchoconstriction long acting beta agonist salmeterol |
exercise challenge bronchoprotection beta 2 adrenergic receptor polymorphisms pharmacogenetics |
Asthma, Exercise-Induced Hypersensitivity Lung Diseases, Obstructive Salmeterol Respiratory Tract Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Immune System Diseases Adrenergic beta-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
Anti-Asthmatic Agents Adrenergic Agonists Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |