A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate in the Treatment of Patients With COPD

NCT ID: NCT00215436

Last Updated: 2010-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

345 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the safety and efficacy of the investigational drug in comparison with a placebo.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Chronic Obstructive Pulmonary Disease COPD formoterol

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Formoterol Fumarate

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Medical diagnosis of COPD
* Current or prior history of cigarette smoking

Exclusion Criteria

* Medical diagnosis of asthma
* Chest X-ray diagnostic of significant disease other than COPD
* Significant condition or disease other than COPD
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dey

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dey L.P.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Jasper, Alabama, United States

Site Status

Research Site

Phoenix, Arizona, United States

Site Status

Research Site

Tuscon, Arizona, United States

Site Status

Research Site

Buena Park, California, United States

Site Status

Research Site

Huntington Beach, California, United States

Site Status

Research Site

Long Beach, California, United States

Site Status

Research Site

Long Beach, California, United States

Site Status

Research Site

Los Angeles, California, United States

Site Status

Research Site

San Diego, California, United States

Site Status

Research Site

Stockton, California, United States

Site Status

Research Site

Denver, Colorado, United States

Site Status

Research Site

Wheat Ridge, Colorado, United States

Site Status

Research Site

Hartford, Connecticut, United States

Site Status

Research Site

Clearwater, Florida, United States

Site Status

Research Site

DeLand, Florida, United States

Site Status

Research Site

Tampa, Florida, United States

Site Status

Research Site

Woodstock, Georgia, United States

Site Status

Research Site

Hines, Illinois, United States

Site Status

Research Site

Normal, Illinois, United States

Site Status

Research Site

Florence, Kentucky, United States

Site Status

Research Site

New Orleans, Louisiana, United States

Site Status

Research Site

Ann Arbor, Michigan, United States

Site Status

Research Site

Minneapolis, Minnesota, United States

Site Status

Research Site

Rochester, Minnesota, United States

Site Status

Research Site

Saint Charles, Missouri, United States

Site Status

Research Site

St Louis, Missouri, United States

Site Status

Research Site

Butte, Montana, United States

Site Status

Research Site

Henderson, Nevada, United States

Site Status

Research Site

Cherry Hill, New Jersey, United States

Site Status

Research Site

Summit, New Jersey, United States

Site Status

Research Site

Albuquerque, New Mexico, United States

Site Status

Research Site

Camillus, New York, United States

Site Status

Research Site

Charlotte, North Carolina, United States

Site Status

Research Site

Cincinnati, Ohio, United States

Site Status

Research Site

Columbus, Ohio, United States

Site Status

Research Site

Medford, Oregon, United States

Site Status

Research Site

Portland, Oregon, United States

Site Status

Research Site

Cranston, Rhode Island, United States

Site Status

Research Site

Spartanburg, South Carolina, United States

Site Status

Research Site

Dallas, Texas, United States

Site Status

Research Site

San Antonio, Texas, United States

Site Status

Research Site

Richmond, Virginia, United States

Site Status

Research Site

Madison, Wisconsin, United States

Site Status

Research Site

Milwaukee, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Nelson HS, Gross NJ, Levine B, Kerwin EM, Rinehart M, Denis-Mize K; Formoterol Study Group. Cardiac safety profile of nebulized formoterol in adults with COPD: a 12-week, multicenter, randomized, double- blind, double-dummy, placebo- and active-controlled trial. Clin Ther. 2007 Oct;29(10):2167-78. doi: 10.1016/j.clinthera.2007.10.007.

Reference Type RESULT
PMID: 18042473 (View on PubMed)

Gross NJ, Nelson HS, Lapidus RJ, Dunn L, Lynn L, Rinehart M, Denis-Mize K; Formoterol Study Group. Efficacy and safety of formoterol fumarate delivered by nebulization to COPD patients. Respir Med. 2008 Feb;102(2):189-97. doi: 10.1016/j.rmed.2007.10.007.

Reference Type RESULT
PMID: 18363201 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201-065

Identifier Type: -

Identifier Source: org_study_id