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Sponsors and Collaborators: |
Henry Ford Health System Sepracor, Inc. |
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Information provided by: | Henry Ford Health System |
ClinicalTrials.gov Identifier: | NCT00819637 |
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.
Condition | Intervention | Phase |
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Acute Asthma |
Drug: arformoterol (RR formoterol) Drug: placebo Drug: levalbuterol |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | 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. |
Estimated Enrollment: | 90 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arformoterol 3 doses: Experimental |
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. |
Arformoterol 1 dose, placebo 2 doses: Experimental |
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.
Group 2 will receive nebulized arformoterol 15 ug first dose and then placebo every 20 minutes for 2 doses.
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Levalbuterol 3 doses: Active Comparator |
Drug: levalbuterol
Group 3 will receive nebulized levalbuterol 1.25 mg every 20 minutes for 3 doses.
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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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Richard M Nowak, MD | 313 916 1909 | rnowak1@hfhs.org |
Contact: Michele Moyer, RN | 313 916 3678 | mmoyer1@hfhs.org |
United States, Michigan | |
Henry Ford Hospital Emergency Department | Recruiting |
Detroit, Michigan, United States, 48202 | |
Contact: Margot LaPointe, PhD 313-916-2024 mlapoin1@hfhs.org | |
Principal Investigator: Richard M Nowak, MD | |
Sub-Investigator: David Amponsah, MD | |
Sub-Investigator: Howard Klausner, MD |
Principal Investigator: | Richard M Nowak, MD | Henry Ford Health System |
Responsible Party: | Henry Ford Hospital ( Richard M. Nowak MD ) |
Study ID Numbers: | ASRC947 |
Study First Received: | January 8, 2009 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00819637 |
Health Authority: | United States: Institutional Review Board |
Acute asthma Arformoterol Long acting beta agonists |
Albuterol Formoterol Emergencies Asthma |
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic beta-Agonists Adrenergic Agents Physiological Effects of Drugs Anti-Asthmatic Agents Reproductive Control Agents |
Pharmacologic Actions Adrenergic Agonists Tocolytic Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |