A Dose-Finding Study Evaluating Safety and Efficacy in Patients With Chronic Obstructive Pulmonary Disease

June 26, 2009 updated by: Dey

A Multi-Center, Randomized, Double-Blind, Parallel-Group, Dose-Finding Trial to Evaluate the Safety and Efficacy of Fluticasone Propionate Combined With Formoterol Fumarate in Patients With Chronic Obstructive Pulmonary Disease

The purpose of the study is to determine the appropriate dose of fluticasone propionate/formoterol fumarate that is closest to Advair Diskus (fluticasone propionate/salmeterol xinafoate using pulmonary function, safety, and levels of study drug in blood plasma in patients with chronic obstructive pulmonary disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

457

Phase

  • Phase 2

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
      • Birmingham, Alabama, United States, 35209
        • Research Site
      • Jasper, Alabama, United States, 35501
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Research Site
    • California
      • Buena Park, California, United States, 90620
        • Research Site
      • Costa Mesa, California, United States, 92626
        • Research Site
      • Encinitas, California, United States, 92024
        • Research Site
      • Los Angeles, California, United States, 90095
        • Research Site
      • San Diego, California, United States, 92120
        • Research Site
    • Colorado
      • Wheat Ridge, Colorado, United States, 80033
        • Research Site
    • Florida
      • Clearwater, Florida, United States, 33765
        • Research Site
      • DeLand, Florida, United States, 32720
        • Research Site
      • Tamarac, Florida, United States, 33321
        • Research Site
      • Tampa, Florida, United States, 33603
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Research Site
      • Woodstock, Georgia, United States, 30189
        • Research Site
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Research Site
    • Illinois
      • Hines, Illinois, United States, 60141
        • Research Site
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Research Site
      • Topeka, Kansas, United States, 66606
        • Research Site
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Research Site
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Research Site
    • Missouri
      • St. Charles, Missouri, United States, 63301
        • Research Site
      • St. Louis, Missouri, United States, 63122
        • Research Site
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Research Site
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08003
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Research Site
    • New York
      • Camillus, New York, United States, 13031
        • Research Site
      • Liverpool, New York, United States, 13088
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Research Site
      • Greenville, North Carolina, United States, 29615
        • Research Site
      • Morrisville, North Carolina, United States, 27560
        • 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
      • Cincinnati, Ohio, United States, 45227
        • 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
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Research Site
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Research Site
    • Texas
      • Austin, Texas, United States, 78750
        • Research Site
      • Dallas, Texas, United States, 75231
        • Research Site
      • San Antonio, Texas, United States, 78229
        • 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
      • Milwaukee, Wisconsin, United States, 53217
        • 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
  • Female of child-bearing potential to use adequate birth control
  • Smoker or ex-smoker with history of at least 10 years of smoking at least one pack of cigarettes per day
  • Meet lung function requirements

Exclusion Criteria:

  • Diagnosis of asthma
  • Other significant disease than COPD
  • Pregnant or lactating female
  • Female 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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: C 10/1
Drug: Fluticasone Propionate/Formoterol Fumarate
Inhalation suspension for nebulization 1000/20 mcg bid for 2 weeks
Drug: Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension for nebulization 1000/10 mcg bid for 2 weeks
Drug: Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension for nebulization 500/20 mcg bid for 2 weeks
Drug: Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension for nebulization 500/10 mcg bid for 2 weeks
Experimental: C 5/2
Drug: Fluticasone Propionate/Formoterol Fumarate
Inhalation suspension for nebulization 1000/20 mcg bid for 2 weeks
Drug: Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension for nebulization 1000/10 mcg bid for 2 weeks
Drug: Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension for nebulization 500/20 mcg bid for 2 weeks
Drug: Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension for nebulization 500/10 mcg bid for 2 weeks
Experimental: C 5/1
Drug: Fluticasone Propionate/Formoterol Fumarate
Inhalation suspension for nebulization 1000/20 mcg bid for 2 weeks
Drug: Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension for nebulization 1000/10 mcg bid for 2 weeks
Drug: Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension for nebulization 500/20 mcg bid for 2 weeks
Drug: Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension for nebulization 500/10 mcg bid for 2 weeks
Experimental: FP 1000
Drug: Fluticasone Propionate
Inhalation Suspension for nebulization 1000 mcg bid for 2 weeks
Experimental: FF 20
Drug: Formoterol Fumarate
Inhalation Solution for nebulization 20 mcg bid for 2 weeks
Active Comparator: AD 250/50
Drug: Fluticasone Propionate/Salmeterol Xinafoate
Inhalation Powder delivered by Diskus device 250/50 mcg bid for 2 weeks
Placebo Comparator: Plc
Drug: Placebo
Inhalation Solution for nebulization 2 mL bid for 2 weeks
Experimental: C 10/2
Drug: Fluticasone Propionate/Formoterol Fumarate
Inhalation suspension for nebulization 1000/20 mcg bid for 2 weeks
Drug: Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension for nebulization 1000/10 mcg bid for 2 weeks
Drug: Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension for nebulization 500/20 mcg bid for 2 weeks
Drug: Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension for nebulization 500/10 mcg bid for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
2-hour post-dose FEV1
Time Frame: 2 weeks
2 weeks
AUC(0-12) and Cmax in plasma
Time Frame: 2 weeks
2 weeks
pre-dose FEV1
Time Frame: 2 weeks
2 weeks
Amount and percent total dose excreted in urine
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
FEV1 AUC(0-2)
Time Frame: 2 weeks
2 weeks
COPD exacerbations
Treatment Emergent Adverse Events
Time Frame: 2 weeks
2 weeks

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

November 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

November 21, 2006

First Submitted That Met QC Criteria

November 22, 2006

First Posted (Estimate)

November 23, 2006

Study Record Updates

Last Update Posted (Estimate)

June 30, 2009

Last Update Submitted That Met QC Criteria

June 26, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191-076

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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