NCT00819637

A Pilot Study to Determine the Most Effective Dose of Arformoterol for Treating Acute Asthmatic Patients

A Pilot Study to Determine the Most Effective Dose of Arformoterol for Treating Acute Asthmatic Patients Presenting to the Emergency Department and to Evaluate Its Side Effect and Safety Profile When Used in This Clinical Situation.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Asthma

Interventions

Type	Name	Description
DRUG	arformoterol (RR formoterol)	Group 1 will receive nebulized arformoterol 15 ug every 20 minutes for 3 doses. Group 2 will receive nebulized arformoterol 15 ug first dose and then placebo every 20 minutes for 2 doses.
DRUG	placebo	Group 2 will receive nebulized arformoterol 15 ug first dose and then placebo every 20 minutes for 2 doses.
DRUG	levalbuterol	Group 3 will receive nebulized levalbuterol 1.25 mg every 20 minutes for 3 doses.

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2009-01-09
• Last updated: 2023-05-24
• Results posted: 2010-06-29

Locations

1 site across 1 country: United States