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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

January 8, 2009
January 9, 2009
February 17, 2010
June 29, 2010
April 6, 2015
January 2009
November 2009   (Final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00819637 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Number of Participants Treated With Arformoteral in Acute Asthma Exacerbation as a Measure of Safety and Tolerability. [ Time Frame: 5 hours ]
  • 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 ]
  • The Mean Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug [ Time Frame: 1 hour ]
  • 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 ]
  • 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 ]
  • The Time Required to Achieve a FEV1 and PEFR > 60% Predicted for Each Dose (Individual and Cumulative) [ Time Frame: 5 hours ]
  • 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.
  • 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.
  • 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 ]
  • Pharmacokinetics of Arformoterol in This Clinical Setting [ Time Frame: 5 hours ]
  • To determine the safety and tolerability of arformoterol when used to treat acute exacerbations of asthma. [ Time Frame: 5 hours ]
  • 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 ]
  • 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 ]
  • The Mean Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug [ Time Frame: 1 hour ]
  • 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 ]
  • 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 ]
  • The Time Required to Achieve a FEV1 and PEFR > 60% Predicted for Each Dose (Individual and Cumulative) [ Time Frame: 5 hours ]
  • Percent of Responders (Defined as Those Discharged Following Treatment Who Did Not Require Additional Therapy in the ED) [ Time Frame: 5 hours ]
  • Percent of Patients in Each Group Requiring Additional Therapies After the First Hour of Study Drug Treatments [ Time Frame: 5 hours ]
  • 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 ]
  • Determine the pharmacokinetics of arformoterol in this clinical setting [ Time Frame: 5 hours ]
Not Provided
Not Provided
 
A Pilot Study to Determine the Most Effective Dose of Arformoterol for Treating Acute Asthmatic Patients
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.
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Asthma
  • 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.
  • Drug: levalbuterol
    Group 3 will receive nebulized levalbuterol 1.25 mg every 20 minutes for 3 doses.
    Other Name: Xopenex
  • Experimental: Arformoterol 3 doses
    Intervention: Drug: arformoterol (RR formoterol)
  • Experimental: Arformoterol 1 dose, placebo 2 doses
    Interventions:
    • Drug: arformoterol (RR formoterol)
    • Drug: placebo
  • Active Comparator: Levalbuterol 3 doses
    Intervention: Drug: levalbuterol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
90
November 2009
November 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00819637
ASRC947
No
Not Provided
Not Provided
Richard M Nowak, Henry Ford Health System
Henry Ford Health System
Sunovion
Principal Investigator: Richard M Nowak, MD Henry Ford Health System
Henry Ford Health System
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP