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

Information source: Dey
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: Fluticasone Propionate/Formoterol Fumarate (Drug); Fluticasone Propionate/Formoterol Fumarate (Drug); Fluticasone Propionate/Formoterol Fumarate (Drug); Fluticasone Propionate/Formoterol Fumarate (Drug); Fluticasone Propionate (Drug); Formoterol Fumarate (Drug); Fluticasone Propionate/Salmeterol Xinafoate (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Dey

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

2-hour post-dose FEV1

AUC(0-12) and Cmax in plasma

pre-dose FEV1

Amount and percent total dose excreted in urine

Secondary outcome:

FEV1 AUC(0-2)

COPD exacerbations

Treatment Emergent Adverse Events

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Research Site, Birmingham, Alabama 35209, United States

Research Site, Jasper, Alabama 35501, United States

Research Site, Phoenix, Arizona 85006, United States

Research Site, Buena Park, California 90620, United States

Research Site, Costa Mesa, California 92626, United States

Research Site, Encinitas, California 92024, United States

Research Site, Los Angeles, California 90095, United States

Research Site, San Diego, California 92120, United States

Research Site, Wheat Ridge, Colorado 80033, United States

Research Site, Clearwater, Florida 33765, United States

Research Site, DeLand, Florida 32720, United States

Research Site, Tamarac, Florida 33321, United States

Research Site, Tampa, Florida 33603, United States

Research Site, Atlanta, Georgia 30309, United States

Research Site, Woodstock, Georgia 30189, United States

Research Site, Coeur d'Alene, Idaho 83814, United States

Research Site, Hines, Illinois 60141, United States

Research Site, Lenexa, Kansas 66219, United States

Research Site, Topeka, Kansas 66606, United States

Research Site, Madisonville, Kentucky 42431, United States

Research Site, Wheaton, Maryland 20902, United States

Research Site, Minneapolis, Minnesota 55402, United States

Research Site, St. Charles, Missouri 63301, United States

Research Site, St. Louis, Missouri 63122, United States

Research Site, Henderson, Nevada 89014, United States

Research Site, Cherry Hill, New Jersey 08003, United States

Research Site, Albuquerque, New Mexico 87108, United States

Research Site, Camillus, New York 13031, United States

Research Site, Liverpool, New York 13088, United States

Research Site, Charlotte, North Carolina 28207, United States

Research Site, Greenville, North Carolina 29615, United States

Research Site, Morrisville, North Carolina 27560, United States

Research Site, Raleigh, North Carolina 27607, United States

Research Site, Cincinnati, Ohio 45242, United States

Research Site, Cincinnati, Ohio 45231, United States

Research Site, Cincinnati, Ohio 45227, United States

Research Site, Oklahoma City, Oklahoma 73104, United States

Research Site, Medford, Oregon 97504, United States

Research Site, Portland, Oregon 97213, United States

Research Site, East Providence, Rhode Island 02914, United States

Research Site, Spartanburg, South Carolina 29303, United States

Research Site, Austin, Texas 78750, United States

Research Site, Dallas, Texas 75231, United States

Research Site, San Antonio, Texas 78229, United States

Research Site, South Burlington, Vermont 05403, United States

Research Site, Abingdon, Virginia 24210, United States

Research Site, Richmond, Virginia 23225, United States

Research Site, Tacoma, Washington 98405, United States

Research Site, Milwaukee, Wisconsin 53217, United States

Additional Information

Starting date: November 2006
Last updated: June 26, 2009

Page last updated: August 20, 2015

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