Status:
TERMINATED
A Pilot Study to Determine the Most Effective Dose of Arformoterol for Treating Acute Asthmatic Patients
Lead Sponsor:
Henry Ford Health System
Collaborating Sponsors:
Sumitomo Pharma America, Inc.
Conditions:
Acute Asthma
Eligibility:
All Genders
18-45 years
Phase:
PHASE4
Brief 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 th...
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 fashi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00819637
Start Date
January 1 2009
End Date
November 1 2009
Last Update
May 24 2023
Active Locations (1)
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1
Henry Ford Hospital Emergency Department
Detroit, Michigan, United States, 48202