A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate 20 Mcg/0.5 mL in the Treatment of Patients With COPD

November 9, 2010 updated by: Dey

A 12-week Double-Blind, Parallel-Group, Placebo- and Active- Controlled Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate Inhalation Solution 20 Mcg/0.5 mL Delivered by OMRON MicroAir NE-U22V Nebulizer in the Treatment of Patients With Chronic Obstructive Pulmonary Disease

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

345

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Jasper, Alabama, United States, 35501
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States, 85006-2666
        • Research Site
    • California
      • Buena Park, California, United States, 90620
        • Research Site
      • Costa Mesa, California, United States, 92626
        • Research Site
      • Huntington Beach, California, United States, 92647
        • Research Site
      • Long Beach, California, United States, 90813
        • Research Site
      • San Diego, California, United States, 92120
        • Research Site
      • Stockton, California, United States, 95207
        • Research Site
      • Walnut Creek, California, United States, 94598
        • Research Site
    • Colorado
      • Denver, Colorado, United States, 80206
        • Research Site
      • Wheat Ridge, Colorado, United States, 80033
        • Research Site
    • Florida
      • Clearwater, Florida, United States, 33765
        • Research Site
      • DeLand, Florida, United States, 32720
        • Research Site
      • Miami Beach, Florida, United States, 33140
        • Research Site
      • Tampa, Florida, United States, 33603
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Research Site
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Research Site
    • Illinois
      • Hines, Illinois, United States, 60141
        • Research Site
      • Normal, Illinois, United States, 61761
        • Research Site
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Research Site
      • Shawnee Mission, Kansas, United States, 66216
        • Research Site
      • Topeka, Kansas, United States, 66606
        • Research Site
    • Massachusetts
      • N. Dartmouth, Massachusetts, United States, 02747
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Research Site
      • Rochester, Minnesota, United States, 55905
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States, 63122
        • Research Site
      • St. Louis, Missouri, United States, 63141
        • Research Site
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Research Site
    • New Jersey
      • Summit, New Jersey, United States, 07901
        • Research Site
    • New York
      • Camillus, New York, United States, 13030
        • Research Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Research Site
      • Charlotte, North Carolina, United States, 28207
        • Research Site
      • Elizabeth City, North Carolina, United States, 27909
        • Research Site
      • Raleigh, North Carolina, United States, 27607
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Research Site
      • Cincinnati, Ohio, United States, 45242
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Research Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Research Site
      • Portland, Oregon, United States, 97213
        • Research Site
    • Pennsylvania
      • Upland, Pennsylvania, United States, 19013
        • Research Site
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
        • Research Site
    • South Carolina
      • Spartanburg, South Carolina, United States, 29307
        • Research Site
    • Texas
      • Austin, Texas, United States, 78750
        • Research Site
      • Dallas, Texas, United States, 75231
        • Research Site
      • Houston, Texas, United States, 77030
        • Research Site
      • Waco, Texas, United States, 76712
        • Research Site
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • Research Site
    • Virginia
      • Abingdon, Virginia, United States, 24210
        • Research Site
      • Richmond, Virginia, United States, 23225
        • Research Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Research Site
      • Milwaukee, Wisconsin, United States, 53209
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure of lung function

Secondary Outcome Measures

Outcome Measure
Change in lung function, as well as vital signs
Physical Exam results, adverse event reporting, etc

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

January 19, 2006

First Submitted That Met QC Criteria

January 19, 2006

First Posted (Estimate)

January 23, 2006

Study Record Updates

Last Update Posted (Estimate)

November 11, 2010

Last Update Submitted That Met QC Criteria

November 9, 2010

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201-069

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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