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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
457

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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