Study in Subjects Greater Than 40 Years of Age With COPD

November 10, 2010 updated by: Dey

A 6-Week Trial to Compare the Efficacy and Safety of Concomitant Treatment With Formoterol Fumarate Inhalation Solution 20 Mcg Twice Daily and Tiotropium 18 Mcg Once Daily to Tiotropium 18 Mcg Once Daily Alone in the Treatment of Patients With Chronic Obstructive Pulmonary Disease

This is a multicenter, Phase IIIb, randomized, double-blind, active-controlled, parallel-group, comparative study.

The objectives of this study are:

  1. To compare the efficacy of tiotropium 18 mcg once daily plus Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg twice daily to tiotropium 18 mcg once daily.
  2. To obtain safety data on the use of tiotropium 18 mcg once daily plus FFIS 20 mcg twice daily compared to tiotropium 18 mcg once daily.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

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
      • Mobile, Alabama, United States, 36695
        • Clinical Research Site
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Clinical Research Site
    • Florida
      • DeLand, Florida, United States, 32720
        • Clinical Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30330
        • Clinical Research Site
    • Michigan
      • Livonia, Michigan, United States, 48152
        • Clinical Research Site
    • Missouri
      • St. Charles, Missouri, United States, 63301
        • Clinical Research Site
      • St. Louis, Missouri, United States, 63141
        • Clinical Research Site
    • New York
      • Albany, New York, United States, 12205
        • Clinical Research Site
      • North Syracuse, New York, United States, 13212
        • Clinical Research Site
      • Williamsville, New York, United States, 14221
        • Clinical Research Site
    • Ohio
      • Toledo, Ohio, United States, 45560
        • Clinical Research Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Clinical Research Site
      • Portland, Oregon, United States, 97213
        • Clinical Research Site
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Clinical Research Site
      • Spartanburg, South Carolina, United States, 29303
        • Clinical Research Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Clinical Research Site
    • Virginia
      • Abingdon, Virginia, United States, 24210
        • Clinical Research Site
      • Richmond, Virginia, United States, 23225
        • Clinical Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Clinical 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
  • 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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary efficacy endpoint will be the standardized area under the curve for FEV1 (FEV1 AUC0-3) over the 3-hour assessment period at End Study (Week 6/ET).
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

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

Sponsor

Dey

Investigators

  • Principal Investigator: Nicola A Hanania, MD, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

July 24, 2007

First Submitted That Met QC Criteria

July 24, 2007

First Posted (Estimate)

July 26, 2007

Study Record Updates

Last Update Posted (Estimate)

November 11, 2010

Last Update Submitted That Met QC Criteria

November 10, 2010

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201-080

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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