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

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henry Ford Health System
• Collaborator: Sunovion
• Treatments: Albuterol; Formoterol Fumarate

Criteria

Inclusion Criteria:

• Signed informed consent

• FEV1 between 20 and 60% predicted after having received 5 mg of albuterol and 0.5 mg of atrovent as nebulized standard of care therapy

• 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