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

Primary Purpose

Acute Asthma

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
arformoterol (RR formoterol)
placebo
levalbuterol
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Asthma focused on measuring Acute asthma, Arformoterol, Long acting beta agonists

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henry Ford Hospital Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Arformoterol 3 doses

Arformoterol 1 dose, placebo 2 doses

Levalbuterol 3 doses

Arm Description

Outcomes

Primary Outcome Measures

The Averaged Mean Percent Change From Baseline FEV1 and PEFR (Percent Predicted and Absolute) After the 3 Doses of Study Drug

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
The study was terminated early and therefore secondary outcome measures were not obtained.
Number of Participants Treated With Arformoteral in Acute Asthma Exacerbation as a Measure of Safety and Tolerability.
The study was terminated early and therefore secondary outcome measures were not obtained.
The Mean Percent Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug
The Mean Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug
The study was terminated early and therefore secondary outcome measures were not obtained.
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
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
The Time Required to Achieve a FEV1 and PEFR > 60% Predicted for Each Dose (Individual and Cumulative)
Percent of Responders (Defined as Those Discharged Following Treatment Who Did Not Require Additional Therapy in the ED)
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
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
Pharmacokinetics of Arformoterol in This Clinical Setting

Full Information

First Posted
January 8, 2009
Last Updated
April 25, 2023
Sponsor
Henry Ford Health System
Collaborators
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00819637
Brief Title
A Pilot Study to Determine the Most Effective Dose of Arformoterol for Treating Acute Asthmatic Patients
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 Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Unable to enroll r/t study design & staffing issues. The trial terminated.
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henry Ford Health System
Collaborators
Sumitomo Pharma America, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Asthma
Keywords
Acute asthma, Arformoterol, Long acting beta agonists

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arformoterol 3 doses
Arm Type
Experimental
Arm Title
Arformoterol 1 dose, placebo 2 doses
Arm Type
Experimental
Arm Title
Levalbuterol 3 doses
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
arformoterol (RR formoterol)
Other Intervention Name(s)
Brovana
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Group 2 will receive nebulized arformoterol 15 ug first dose and then placebo every 20 minutes for 2 doses.
Intervention Type
Drug
Intervention Name(s)
levalbuterol
Other Intervention Name(s)
Xopenex
Intervention Description
Group 3 will receive nebulized levalbuterol 1.25 mg every 20 minutes for 3 doses.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Description
The study was terminated early and therefore secondary outcome measures were not obtained.
Time Frame
1 hour
Title
Number of Participants Treated With Arformoteral in Acute Asthma Exacerbation as a Measure of Safety and Tolerability.
Description
The study was terminated early and therefore secondary outcome measures were not obtained.
Time Frame
5 hours
Title
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
Title
The Mean Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug
Description
The study was terminated early and therefore secondary outcome measures were not obtained.
Time Frame
1 hour
Title
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
Title
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
Title
The Time Required to Achieve a FEV1 and PEFR > 60% Predicted for Each Dose (Individual and Cumulative)
Time Frame
5 hours
Title
Percent of Responders (Defined as Those Discharged Following Treatment Who Did Not Require Additional Therapy in the ED)
Description
The 2 subjects enrolled were both discharged home after study protocol completion, with no further treatment required in the ED setting.
Time Frame
5 hours
Title
Percent of Patients in Each Group Requiring Additional Therapies After the First Hour of Study Drug Treatments
Description
2 subjects were enrolled. Neither required additional asthma treatment after the 1st hour of study drug teatments.
Time Frame
5 hours
Title
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
Title
Pharmacokinetics of Arformoterol in This Clinical Setting
Time Frame
5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard M Nowak, MD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Hospital Emergency Department
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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