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

This study has been terminated.
(Unable to enroll r/t study design & staffing issues. The trial terminated.)
Sponsor:
Collaborator:
Sunovion
Information provided by:
Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT00819637
First received: January 8, 2009
Last updated: May 25, 2010
Last verified: January 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
  • Number of Participants Treated With Arformoteral in Acute Asthma Exacerbation as a Measure of Safety and Tolerability. [ Time Frame: 5 hours ] [ Designated as safety issue: Yes ]
  • 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 ]
    The 2 subjects enrolled were both discharged home after study protocol completion, with no further treatment required in the ED setting.

  • 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 ]
    2 subjects were enrolled. Neither required additional asthma treatment after the 1st hour of study drug teatments.

  • 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 ]
  • Pharmacokinetics of Arformoterol in This Clinical Setting [ Time Frame: 5 hours ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: January 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Placebo
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

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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Richard M. Nowak MD, Henry Ford Hospital
ClinicalTrials.gov Identifier: NCT00819637     History of Changes
Other Study ID Numbers: ASRC947
Study First Received: January 8, 2009
Results First Received: February 17, 2010
Last Updated: May 25, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 20, 2014