NCT00215397

Brief Summary

The purpose of this study is to determine which dose of the investigational drug is the most safe and effective in the treatment of asthma compared to the control drug.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_2 asthma

Geographic Reach
1 country

3 active sites

Status
completed

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

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

November 11, 2010

Status Verified

February 1, 2008

First QC Date

September 13, 2005

Last Update Submit

November 10, 2010

Conditions

Asthma

Keywords

AsthmaFormoterolFumarate

Outcome Measures

Primary Outcomes (1)

  • The primary outcome variable is the measure of lung function.

Secondary Outcomes (2)

  • Secondary outcomes include change in lung function, as well as in vital signs.

  • Physical exams, AE reporting, etc.

Interventions

Formoterol FumarateDRUG

Eligibility Criteria

Age5 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a history of asthma

You may not qualify if:

  • Current asthma exacerbation or recent asthma exacerbation, requiring hospitalization
  • History of smoking
  • Debilitating systemic and/or life-threatening diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Long Beach, California, 90806, United States

Location

Research Site

Denver, Colorado, 80206, United States

Location

Research Site

Medford, Oregon, 97504, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Formoterol Fumarate

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Primary Completion

February 1, 2003

Study Completion

December 1, 2005

Last Updated

November 11, 2010

Record last verified: 2008-02

Locations

US(3)