NCT00215410

Brief Summary

The purpose of this study is to determine the most safe and effective dose of the investigational drug in comparison with a control drug and placebo.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for phase_2 asthma

Geographic Reach
1 country

12 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

October 1, 2003

Completed
2 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
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 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

Keywords

AsthmaFormoterolFumarate

Outcome Measures

Primary Outcomes (1)

  • Measure of lung function

Secondary Outcomes (2)

  • Change in lung function, as well as vital signs

  • Physical Exam results, AE reporting, etc

Interventions

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with a history of asthma
  • Written guardian approval

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Research Site

Little Rock, Arkansas, 72205, United States

Location

Research Site

Long Beach, California, 90806, United States

Location

Research Site

Mission Viejo, California, 92691, United States

Location

Research Site

Newport Beach, California, 92660, United States

Location

Research Site

Orange, California, 92888, United States

Location

Research Site

Vista, California, 92084, United States

Location

Research Site

Englewood, Colorado, 80112, United States

Location

Research Site

Oklahoma City, Oklahoma, 73120, United States

Location

Research Site

Medford, Oregon, 97504, United States

Location

Research Site

Portland, Oregon, 97213, United States

Location

Research Site

Fort Worth, Texas, 76107, United States

Location

Research Site

Houston, Texas, 77054, 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

October 1, 2003

Study Completion

October 1, 2005

Last Updated

November 11, 2010

Record last verified: 2008-02

Locations