NCT00819637

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
8 months until next milestone

Results Posted

Study results publicly available

June 29, 2010

Completed
Last Updated

May 24, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

January 8, 2009

Results QC Date

February 17, 2010

Last Update Submit

April 25, 2023

Conditions

Acute Asthma

Keywords

Acute asthmaArformoterolLong acting beta agonists

Outcome Measures

Primary Outcomes (1)

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

    1 hour

Secondary Outcomes (11)

  • 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

    1 hour

  • Number of Participants Treated With Arformoteral in Acute Asthma Exacerbation as a Measure of Safety and Tolerability.

    5 hours

  • The Mean Percent Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug

    1 hour

  • The Mean Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug

    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

    1 hour

  • +6 more secondary outcomes

Study Arms (3)

Arformoterol 3 doses

EXPERIMENTAL
Drug: arformoterol (RR formoterol)

Arformoterol 1 dose, placebo 2 doses

EXPERIMENTAL
Drug: arformoterol (RR formoterol)Drug: placebo

Levalbuterol 3 doses

ACTIVE COMPARATOR
Drug: levalbuterol

Interventions

arformoterol (RR formoterol)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.

Also known as: Brovana
Arformoterol 1 dose, placebo 2 dosesArformoterol 3 doses
placeboDRUG

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
levalbuterolDRUG

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

Also known as: Xopenex
Levalbuterol 3 doses

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Hospital Emergency Department

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Interventions

Formoterol FumarateLevalbuterol

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesAlbuterolPhenethylaminesEthylamines

Results Point of Contact

Title
Richard M Nowak MD
Organization
Henry Ford Health System, Detroit, Michigan
rnowak1@hfhs.staff
313 881 0023

Study Officials

  • Richard M Nowak, MD

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2009

First Posted

January 9, 2009

Study Start

January 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

May 24, 2023

Results First Posted

June 29, 2010

Record last verified: 2023-04

Locations

US(1)