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

NCT00819637 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-05-24

Study results available
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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.

Conditions

  • Acute Asthma

Interventions

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.

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.

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    collaborator INDUSTRY
  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • Richard M Nowak, MD · Henry Ford Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00819637 on ClinicalTrials.gov