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

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ClinicalTrials.gov Identifier: NCT00819637
Recruitment Status : Terminated (Unable to enroll r/t study design & staffing issues. The trial terminated.)
First Posted : January 9, 2009
Results First Posted : June 29, 2010
Last Update Posted : April 6, 2015
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Richard M Nowak, Henry Ford Health System

Study Description
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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 the Emergency Department. Also this study will evaluate the side effect and safety profile of arformoterol when used in this situation.

Condition or disease Intervention/treatment Phase
Acute Asthma Drug: arformoterol (RR formoterol) Drug: placebo Drug: levalbuterol Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : January 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arformoterol 3 doses 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.

Other Name: Brovana
Experimental: Arformoterol 1 dose, placebo 2 doses 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.

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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Number of Participants Treated With Arformoteral in Acute Asthma Exacerbation as a Measure of Safety and Tolerability. [ Time Frame: 5 hours ]
  3. 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 ]
  4. The Mean Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug [ Time Frame: 1 hour ]
  5. 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 ]
  6. 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 ]
  7. The Time Required to Achieve a FEV1 and PEFR > 60% Predicted for Each Dose (Individual and Cumulative) [ Time Frame: 5 hours ]
  8. Percent of Responders (Defined as Those Discharged Following Treatment Who Did Not Require Additional Therapy in the ED) [ Time Frame: 5 hours ]
    The 2 subjects enrolled were both discharged home after study protocol completion, with no further treatment required in the ED setting.

  9. Percent of Patients in Each Group Requiring Additional Therapies After the First Hour of Study Drug Treatments [ Time Frame: 5 hours ]
    2 subjects were enrolled. Neither required additional asthma treatment after the 1st hour of study drug teatments.

  10. 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 ]
  11. Pharmacokinetics of Arformoterol in This Clinical Setting [ Time Frame: 5 hours ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00819637


Locations
United States, Michigan
Henry Ford Hospital Emergency Department
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Sunovion
Investigators
Principal Investigator: Richard M Nowak, MD Henry Ford Health System
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Richard M Nowak, Sr. Staff Physician DEM, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT00819637     History of Changes
Other Study ID Numbers: ASRC947
First Posted: January 9, 2009    Key Record Dates
Results First Posted: June 29, 2010
Last Update Posted: April 6, 2015
Last Verified: March 2015

Keywords provided by Richard M Nowak, Henry Ford Health System:
Acute asthma
Arformoterol
Long acting beta agonists

Additional relevant MeSH terms:
Formoterol Fumarate
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
 Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents