NCT00215371

Brief Summary

The purpose of this study is to determine which dose of the investigational drug is safest and most effective compared to the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_2 asthma

Timeline
Completed

Started Jul 2002

Longer than P75 for phase_2 asthma

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

July 1, 2002

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2002

Completed
3 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
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

November 11, 2010

Status Verified

February 1, 2008

Enrollment Period

3 months

First QC Date

September 13, 2005

Last Update Submit

November 10, 2010

Conditions

Asthma

Keywords

AsthmaPediatricFormoterol FumarateForadil

Outcome Measures

Primary Outcomes (1)

  • Primary: The primary efficacy outcome is measure of lung function.

Secondary Outcomes (1)

  • Secondary: Change in lung function will be examined as a secondary efficacy outcome, as well as vital signs, physical examination, adverse event reporting,etc.

Interventions

Formoterol FumarateDRUG

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Require the regular use of an inhaled beta-2-selective adrenergic agent.
  • No clinically significant abnormalities on the medical history, physical examination, and clinical laboratory tests.

You may not qualify if:

  • Active acute or chronic disorders of the respiratory system within one month prior to screening.
  • Smoking history within the past 12 months or greater than a lifetime 10 pack-year smoking history.
  • Debilitating systemic and/or life-threatening diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Long Beach, California, 90806, 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

Study Start

July 1, 2002

Primary Completion

October 1, 2002

Study Completion

November 1, 2005

Last Updated

November 11, 2010

Record last verified: 2008-02

Locations

US(2)