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A Pilot Study to Determine the Most Effective Dose of Arformoterol for Treating Acute Asthmatic Patients - NCT00819637-48202(Clinical Trial 262987)



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City:  Detroit
State:  
MI
Zip Code: 48202
Conditions: Acute Asthma
Purpose: The purpose of this study is to determine the best dose of nebulized arformoterol, a quick onset but long acting beta agonist, for use in treating acute bronchospasm in asthmatics presenting to the the Emergency Department. Also this study will evaluate the side effect and safety profile of arformoterol when used in this situation.
Study summary: Acute bronchospasm associated with exacerbations of asthma is a common problem. Currently the mainstay of treatment is inhalation albuterol, either levalbuterol or racemic mixture, in repetitive fashion depending on the resolution of the airways obstruction. Formoterol is a long-acting (>12 hours) selective beta2-agonist that has a very rapid onset of bronchodilatation (<3 minutes and thus similar to that produced by albuterol). Patients with acute bronchospasm could benefit from the prn use of formoterol as they would receive acute relief of their symptoms and this would last for a prolonged time period. Additionally formoterol has been reported to be 28-109 times as potent as albuterol and safe at doses of 54ug in healthy subjects and asthmatics. Racemic formoterol structurally has 2 chiral centers and thus is composed of 4 enantiomers. The RR form (or arformoterol) is the active bronchodilator and it is not clear what the physiologic actions of the other 3 enantiomers are. This study is the first to evaluate nebulized arformoterol solution for therapy of acute asthmatics presenting to the Emergency Department.
Criteria: Inclusion Criteria: - Signed informed consent - FEV1 between 20 and 60% predicted - Male or female between the ages of 18 and 45 - Asthma diagnosed by a physician and present for at least 6 months - oxygen saturation greater or equal to 90% on room air - Non smoker or < 10 pack-year history - No other cause for wheezing/sob as determined by the treating physician Exclusion Criteria: - Clinical evidence or history of hepatic, renal, cardiovascular, GI, endocrine, metabolic or CNS disease which might interfere with the conduct of the study - Acute respiratory failure or other significant pathology of the pulmonary system - Female subjects who are pregnant or lactating - Currently receiving therapy for a psychiatric disorder - Subjects with a known sensitivity to formoterol (racemic or RR) or albuterol (racemic or lev) - History of hospitalization for asthma within 2 months or treatment for acute asthma in an ED within 2 weeks of study entry - Past or current use of disallowed medications - Participation in an investigational study within 30 days
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Data Source: ClinicalTrials.gov
Date Processed: June 22, 2010
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