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

NCT ID: NCT00403286

Last Updated: 2009-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

457 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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Chronic Obstructive Pulmonary Disease COPD Safety Efficacy Pharmacokinetic Dose-finding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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C 10/1

Group Type EXPERIMENTAL

Fluticasone Propionate/Formoterol Fumarate

Intervention Type DRUG

Inhalation Suspension for nebulization 1000/10 mcg bid for 2 weeks

C 5/2

Group Type EXPERIMENTAL

Fluticasone Propionate/Formoterol Fumarate

Intervention Type DRUG

Inhalation Suspension for nebulization 500/20 mcg bid for 2 weeks

C 5/1

Group Type EXPERIMENTAL

Fluticasone Propionate/Formoterol Fumarate

Intervention Type DRUG

Inhalation Suspension for nebulization 500/10 mcg bid for 2 weeks

FP 1000

Group Type EXPERIMENTAL

Fluticasone Propionate

Intervention Type DRUG

Inhalation Suspension for nebulization 1000 mcg bid for 2 weeks

FF 20

Group Type EXPERIMENTAL

Formoterol Fumarate

Intervention Type DRUG

Inhalation Solution for nebulization 20 mcg bid for 2 weeks

AD 250/50

Group Type ACTIVE_COMPARATOR

Fluticasone Propionate/Salmeterol Xinafoate

Intervention Type DRUG

Inhalation Powder delivered by Diskus device 250/50 mcg bid for 2 weeks

Plc

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Inhalation Solution for nebulization 2 mL bid for 2 weeks

C 10/2

Group Type EXPERIMENTAL

Fluticasone Propionate/Formoterol Fumarate

Intervention Type DRUG

Inhalation suspension for nebulization 1000/20 mcg bid for 2 weeks

Interventions

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Fluticasone Propionate/Formoterol Fumarate

Inhalation suspension for nebulization 1000/20 mcg bid for 2 weeks

Intervention Type DRUG

Fluticasone Propionate/Formoterol Fumarate

Inhalation Suspension for nebulization 1000/10 mcg bid for 2 weeks

Intervention Type DRUG

Fluticasone Propionate/Formoterol Fumarate

Inhalation Suspension for nebulization 500/20 mcg bid for 2 weeks

Intervention Type DRUG

Fluticasone Propionate/Formoterol Fumarate

Inhalation Suspension for nebulization 500/10 mcg bid for 2 weeks

Intervention Type DRUG

Fluticasone Propionate

Inhalation Suspension for nebulization 1000 mcg bid for 2 weeks

Intervention Type DRUG

Formoterol Fumarate

Inhalation Solution for nebulization 20 mcg bid for 2 weeks

Intervention Type DRUG

Fluticasone Propionate/Salmeterol Xinafoate

Inhalation Powder delivered by Diskus device 250/50 mcg bid for 2 weeks

Intervention Type DRUG

Placebo

Inhalation Solution for nebulization 2 mL bid for 2 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dey

INDUSTRY

Sponsor Role lead

Responsible Party

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Dey, L.P.

Locations

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Research Site

Birmingham, Alabama, United States

Site Status

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Jasper, Alabama, United States

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Phoenix, Arizona, United States

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Buena Park, California, United States

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Costa Mesa, California, United States

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Encinitas, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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Wheat Ridge, Colorado, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Woodstock, Georgia, United States

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Coeur d'Alene, Idaho, United States

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Hines, Illinois, United States

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Lenexa, Kansas, United States

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Topeka, Kansas, United States

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Madisonville, Kentucky, United States

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Wheaton, Maryland, United States

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Minneapolis, Minnesota, United States

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Saint Charles, Missouri, United States

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St Louis, Missouri, United States

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Henderson, Nevada, United States

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Cherry Hill, New Jersey, United States

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Albuquerque, New Mexico, United States

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Camillus, New York, United States

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Liverpool, New York, United States

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Charlotte, North Carolina, United States

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Greenville, North Carolina, United States

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Morrisville, North Carolina, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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East Providence, Rhode Island, United States

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Spartanburg, South Carolina, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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South Burlington, Vermont, United States

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Abingdon, Virginia, United States

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Richmond, Virginia, United States

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Tacoma, Washington, United States

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Milwaukee, Wisconsin, United States

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Countries

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United States

Other Identifiers

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191-076

Identifier Type: -

Identifier Source: org_study_id