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A Pilot Study to Determine the Most Effective Dose of Arformoterol for Treating Acute Asthmatic Patients
This study is currently recruiting participants.
Verified by Henry Ford Health System, January 2009
Sponsors and Collaborators: Henry Ford Health System
Sepracor, Inc.
Information provided by: Henry Ford Health System
ClinicalTrials.gov Identifier: NCT00819637
  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.


Condition Intervention Phase
Acute Asthma
Drug: arformoterol (RR formoterol)
Drug: placebo
Drug: levalbuterol
Phase IV

MedlinePlus related topics: Asthma
Drug Information available for: Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate Albuterol sulfate Albuterol Levalbuterol hydrochloride Levalbuterol tartrate
U.S. FDA Resources
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.

Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • To determine the most effective dose of inhalation arformoterol for treating acute bronchospasm in asthmatics by evaluating the averaged mean percent change from baseline % predicted FEV1 after 3 doses of study medication in each of the 3 groups [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the safety and tolerability of arformoterol when used to treat acute exacerbations of asthma. [ Time Frame: 5 hours ] [ Designated as safety issue: Yes ]
  • The averaged mean percent change from baseline FEV1 and PEFR (percent predicted and absolute) after the 3 doses of study drug [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • The mean percent change from baseline in the FEV1 and PEFR (absolute and percent predicted) following each dose of study drug [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • The mean change from baseline in the FEV1 and PEFR (absolute and percent predicted) following each dose of study drug [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • The peak change (liters) and peak percent change from baseline in the FEV1 and PEFR (absolute and percent predicted) following each dose of study drug [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • The time to onset of a 15% improvement in FEV1 for each dose (individual and cumulative) and total dose of study medication to reach this [ Time Frame: 5 hour ] [ Designated as safety issue: No ]
  • The time required to achieve a FEV1 and PEFR > 60% predicted for each dose (individual and cumulative) [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
  • Percent of responders (defined as those discharged following treatment who did not require additional therapy in the ED) [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
  • Percent of patients in each group requiring additional therapies after the first hour of study drug treatments [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
  • All of the primary and secondary endpoints partitioned by the presenting PFT in quartiles and the presenting S albuterol levels in quartiles [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
  • Determine the pharmacokinetics of arformoterol in this clinical setting [ Time Frame: 5 hours ] [ Designated as safety issue: No ]

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
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.

Drug: placebo
Group 2 will receive nebulized arformoterol 15 ug first dose and then placebo every 20 minutes for 2 doses.
Levalbuterol 3 doses: Active Comparator Drug: levalbuterol
Group 3 will receive nebulized levalbuterol 1.25 mg every 20 minutes for 3 doses.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819637

Contacts
Contact: Richard M Nowak, MD 313 916 1909 rnowak1@hfhs.org
Contact: Michele Moyer, RN 313 916 3678 mmoyer1@hfhs.org

Locations
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            
Sponsors and Collaborators
Henry Ford Health System
Sepracor, Inc.
Investigators
Principal Investigator: Richard M Nowak, MD Henry Ford Health System
  More Information

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

Keywords provided by Henry Ford Health System:
Acute asthma
Arformoterol
Long acting beta agonists

Study placed in the following topic categories:
Albuterol
Formoterol
Emergencies
Asthma

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009