NCT00215423

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

7 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

December 1, 2003

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
12 days 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
Last Updated

November 11, 2010

Status Verified

August 1, 2008

First QC Date

September 13, 2005

Last Update Submit

November 10, 2010

Conditions

COPDChronic Obstructive Pulmonary Disease

Keywords

COPDChronic Obstructive Pulmonary DiseaseFormoterol FumarateFormoterol

Outcome Measures

Primary Outcomes (1)

  • Measure of lung function

Secondary Outcomes (2)

  • Change in lung function, as well as vital signs

  • Physical Exam results, adverse event 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:

  • Diagnosis of COPD
  • History of cigarette smoking

You may not qualify if:

  • Clinical diagnosis of asthma
  • Significant pulmonary disease other than COPD
  • Other significant major organ disease(s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Research Site

Phoenix, Arizona, 85006-2666, United States

Location

Research Site

Wheat Ridge, Colorado, 80033, United States

Location

Research Site

Hines, Illinois, 60141, United States

Location

Research Site

Shawnee Mission, Kansas, 66216, United States

Location

Research Site

Butte, Montana, 59701, United States

Location

Research Site

Omaha, Nebraska, 68134, United States

Location

Research Site

Medford, Oregon, 97504, United States

Location

Related Publications (1)

  • Gross NJ, Kerwin E, Levine B, Kim KT, Denis-Mize K, Hamzavi M, Carpenter M, Rinehart M. Nebulized formoterol fumarate: Dose selection and pharmacokinetics. Pulm Pharmacol Ther. 2008 Oct;21(5):818-23. doi: 10.1016/j.pupt.2008.07.002. Epub 2008 Jul 8.

    PMID: 18655841RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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

December 1, 2003

Study Completion

September 1, 2005

Last Updated

November 11, 2010

Record last verified: 2008-08

Locations

US(7)