A Crossover Study in the Treatment of Patients With COPD

March 3, 2009 updated by: Dey
The purpose of this study is to compare the efficacy of Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg BID to Combivent® Inhalation Aerosol [2 inhalations from metered dose inhaler (MDI)of 18 mcg ipratropium bromide and 103 mcg albuterol sulfate QID], and to Compare the preference/compliance of BID nebulization to QID use of MDI

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

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
    • California
      • San Diego, California, United States, 92120
        • Research Site
    • Colorado
      • Denver, Colorado, United States, 80206
        • Research Site
      • Wheat Ridge, Colorado, United States, 80033
        • Research Site
    • Florida
      • Panama City, Florida, United States, 32405
        • Research Site
      • Pensacola, Florida, United States, 32504
        • Research Site
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Research Site
    • Louisiana
      • Sunset, Louisiana, United States, 70584
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97213
        • Research Site
    • South Carolina
      • Gaffney, South Carolina, United States, 29340
        • Research Site
      • Spartanburg, South Carolina, United States, 29303
        • Research Site
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
        • Research Site
    • Texas
      • San Antonio, Texas, United States, 78205
        • Research Site
    • Washington
      • Spokane, Washington, United States, 99204
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • 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:

  • Diagnosis of COPD
  • Smoker or exsmoker with at least 10 years smoking at least one pack of cigarettes per day
  • Meet lung function requirements

Exclusion Criteria:

  • Diagnosis of Asthma
  • Significant disease other than COPD
  • Female pregnant or lactating or planning to become pregnant

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: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Lung function after 2 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Lung function at each time point, patient questionnaires, medication compliance,
adverse events, clinical labs, vital signs, ECGs, physical exams

Collaborators and Investigators

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

Sponsor

Dey

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

May 1, 2007

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

April 17, 2007

First Submitted That Met QC Criteria

April 17, 2007

First Posted (Estimate)

April 19, 2007

Study Record Updates

Last Update Posted (Estimate)

March 4, 2009

Last Update Submitted That Met QC Criteria

March 3, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201-081

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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