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

NCT ID: NCT00819637

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-11-30

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.

Conditions

Acute Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arformoterol 3 doses

Group Type: EXPERIMENTAL

arformoterol (RR formoterol)

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

arformoterol (RR formoterol)

Intervention Type: DRUG

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.

placebo

Intervention Type: DRUG

Group 2 will receive nebulized arformoterol 15 ug first dose and then placebo every 20 minutes for 2 doses.

Levalbuterol 3 doses

Group Type: ACTIVE_COMPARATOR

levalbuterol

Intervention Type: DRUG

Group 3 will receive nebulized levalbuterol 1.25 mg every 20 minutes for 3 doses.

Interventions

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.

Intervention Type: DRUG

placebo

Group 2 will receive nebulized arformoterol 15 ug first dose and then placebo every 20 minutes for 2 doses.

Intervention Type: DRUG

levalbuterol

Group 3 will receive nebulized levalbuterol 1.25 mg every 20 minutes for 3 doses.

Intervention Type: DRUG

Other Intervention Names

Brovana; Xopenex

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: collaborator

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard M Nowak, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

Henry Ford Hospital Emergency Department

Detroit, Michigan, United States

Countries

United States

Other Identifiers

ASRC947

Identifier Type: -

Identifier Source: org_study_id